Laser energy delivery devices including distal tip orientation indicators

ABSTRACT

A laser ablation catheter includes a distal tip, and the distal tip includes a body that defines a longitudinal axis. A first orientation indicator is formed on the body, and the first orientation indicator has an alphanumeric shape. A second orientation indicator is formed on the body. The second orientation indicator is disposed relative to the first orientation indicator such that when the distal tip is viewed in a first side view, the second orientation indicator and the first orientation indicator overlap, appear as the alphanumeric shape, and visually contrast with the body. The second orientation indicator is configured such that when the distal tip is viewed in a second side view, the second orientation indicator appears as the alphanumeric shape and visually contrasts with the body, the second side view and the first side view being substantially 90 degrees apart about the longitudinal axis.

CROSS-REFERENCE TO RELATED APPLICATION

Not Applicable.

FIELD

The present disclosure relates generally to devices, methods and systemsfor controlling a laser energy delivery device, and more specifically,to devices, methods, and systems for controlling a laser energy deliverydevice of a laser ablation system for use in ablating tissue.

BACKGROUND

Arteries are the primary blood vessels that are responsible forproviding blood and oxygen to muscles throughout the body. Arterialdisease occurs when arteries become narrowed or blocked by a buildup ofplaque (for example, atherosclerotic plaque or other deposits). A severeblockage of a peripheral artery may cause non-healing ulcers on the legsand feet, walking pain, rest pain, and/or the potential need foramputation. Arterial blockage by clots formed in a human body may berelieved in a number of traditional ways. Drug therapy, includingnitrates, beta-blockers, and peripheral vasodilatator drugs to dilatethe arteries or thrombolytic drugs to dissolve the clot, can beeffective. If drug treatment fails, angioplasty may be used to reform orremove the atherosclerotic plaque or other deposits in the artery.

Traditional balloon angioplasty is sometimes used to address theblockage by inserting a narrow, flexible tube having a balloon into anartery in the arm or leg. The blocked area in the artery can bestretched apart by passing the balloon to the desired treatment site andgently inflating it to a certain degree. In the event drug therapy isineffective or angioplasty is too risky (often introduction of a balloonin an occluded artery can cause portions of the atherosclerotic materialto become dislodged which may cause a total blockage at a pointdownstream of the subject occlusion thereby requiring emergencyprocedures), a procedure known as excimer laser angioplasty may beindicated.

Excimer laser angioplasty procedure is similar in some respects toconventional coronary balloon angioplasty. A narrow, flexible tube, thelaser catheter, is inserted into an artery in the arm or leg. The lasercatheter contains one or more optical fibers, which can transmit laserenergy. The laser catheter is then advanced inside the artery to thetargeted obstruction at the desired treatment site. After the lasercatheter has been positioned, the laser is energized to “remove” theobstruction.

In many procedures, the lesion is often engaged similar to conventionalballoon angioplasty by crossing the blockage with a guide wire. Thelaser catheter's thin, flexible optical fibers facilitate the desiredpositioning and alignment of the catheter. Using the excimer laser, theclinician performs a controlled blockage removal by sending bursts ofultraviolet light through the catheter and against the blockage, aprocess called “ablation.” The catheter is then slowly advanced throughthe blockage reopening the artery. If there are multiple blockages, thecatheter is advanced to the next blockage site and the above step isrepeated. When the indicated blockages appear to be cleared, thecatheter is withdrawn.

Some previous laser catheters include components that augment theablation process, such as aspiration components for removing ablated andother undesired materials. However, previous laser catheters typicallylack coordination between transmission of laser energy and actuation ofthe components that augment the ablation process.

SUMMARY

These and other shortcomings are addressed by the various aspects,embodiments, and configurations of the present disclosure.

A laser energy delivery device in accordance with this disclosure forproviding treatment to a subject may include a housing; a couplingcarried by the housing and adapted to couple to a laser energygenerator; a sheath carried by the housing, the sheath comprising adistal end adapted to be disposed in the subject; a plurality oftransport members carried by the sheath, the plurality of transportmembers adapted to receive laser energy at the coupling, transmit laserenergy through the sheath, and deliver laser energy to the subject; acontroller carried by the housing; a prime mover carried by the housingand adapted to be actuated by the controller; a drive wire carried bythe sheath and eccentrically coupled to the distal end of the sheath,the drive wire adapted to be rotatably driven by the prime mover androtating to eccentrically rotate the distal end of the sheath; and aplurality of visual indicators carried by the housing, wherein thecontroller is adapted to energize the plurality of visual indicatorsbased on a rotational position of the prime mover relative to thehousing.

The laser energy delivery device of paragraph [0009], wherein thecontroller is adapted to energize at least one of the visual indicatorswhen the rotational position of the prime mover reaches a threshold.

The laser energy delivery device of any of paragraphs [0009] to [0010],wherein each visual indicator of the plurality of visual indicatorscorresponds to a portion of a rotational range of the prime mover, andwherein the controller is adapted to energize each visual indicator whenthe rotational position of the prime mover is within the portion of therotational range of each visual indicator.

The laser energy delivery device of any of paragraphs [0009] to [0011],further comprising a sensor adapted to detect transmission of laserenergy through at least one of the plurality of transport members.

The laser energy delivery device of any of paragraphs [0009] to [0012],wherein the sensor is adapted to send a signal in response to detectingtransmission of laser energy through the at least one of the pluralityof transport members, wherein the controller is adapted to receive thesignal from the sensor, and further comprising an ancillary deviceadapted to augment treatment of the subject via the laser energydelivery device, the controller actuating the ancillary device uponreceiving the signal from the sensor.

The laser energy delivery device of paragraphs [0009] to [0013], whereinthe ancillary device comprises: the prime mover; and a drive wireeccentrically coupled to the distal end of the sheath and adapted to berotatably driven by the prime mover, the drive wire rotating toeccentrically rotate the distal end of the sheath.

The laser energy delivery device of paragraphs [0009] to [0014], whereinthe at least one of the plurality of transport members extends from aproximal end to a distal end, and the sensor is adapted to detectemission of laser energy at a location on the at least one of theplurality of transport members disposed between the proximal end and thedistal end.

The laser energy delivery device of paragraphs [0009] to [0015], whereinthe at least one of the plurality of transport members comprises a bendformed between the proximal end and the distal end, and the sensor isadapted to detect emission of laser energy at the bend.

A laser energy delivery device in accordance with this disclosure forproviding treatment to a subject may include a coupling adapted tocouple to a laser energy generator; a sheath coupled to the coupling,the sheath including a distal end adapted to be disposed in the subject;a plurality of transport members carried by the coupling and the sheath,the plurality of transport members adapted to receive laser energy atthe coupling, transmit laser energy through the sheath, and deliverlaser energy to the subject; and a sensor adapted to detect transmissionof laser energy through at least one of the plurality of transportmembers.

The laser energy delivery device of paragraph [0017], wherein the sensoris adapted to send a signal in response to detecting transmission oflaser energy through the at least one of the plurality of transportmembers, and further including a controller adapted to receive thesignal from the sensor; and an ancillary device adapted to augmenttreatment of the subject via the laser energy delivery device, thecontroller actuating the ancillary device upon receiving the signal fromthe sensor.

The laser energy delivery device of any of paragraphs [0017] to [0018],wherein the ancillary devices includes a prime mover adapted to beactuated by the controller; and a drive wire eccentrically coupled tothe distal end of the sheath and adapted to be rotatably driven by theprime mover, the drive wire rotating to eccentrically rotate the distalend of the sheath.

The laser energy delivery device of any of paragraphs [0017] to [0019],further including a control panel including an input operatively coupledto the controller, the input being actuatable by a clinician to causethe laser energy delivery device to enter and exit an automatic mode, inthe automatic mode the controller actuating the ancillary device uponreceiving the signal from the sensor.

The laser energy delivery device of any of paragraphs [0017] to [0020],wherein the input is a first input, and the control panel furtherincludes a second input operatively coupled to the controller, thesecond input being actuatable by the clinician to cause the controllerto actuate the ancillary device regardless of whether the controllerreceives the signal from the sensor.

The laser energy delivery device of any of paragraphs [0017] to [0021],wherein the at least one of the plurality of transport members extendsfrom a proximal end to a distal end, and the sensor is adapted to detectemission of laser energy at a location on the at least one of theplurality of transport members disposed between the proximal end and thedistal end.

The laser energy delivery device of any of paragraphs [0017] to [0022],wherein the at least one of the plurality of transport members includesa bend formed between the proximal end and the distal end, and thesensor is adapted to detect emission of laser energy at the bend.

The laser energy delivery device of any of paragraphs [0017] to [0023],wherein the sensor includes a photodiode.

A non-transitory tangible computer-readable storage medium having storedthereon instructions which, when executed by a processor, cause theprocessor to perform a method that may include detecting transmission oflaser energy through at least one of a plurality of laser energytransport members of a laser energy delivery device; and sending asignal to actuate an ancillary device of the laser energy deliverydevice in response to detecting transmission of laser energy through theat least one of the plurality of transport members.

The non-transitory tangible computer-readable storage medium ofparagraph [0025], wherein the ancillary device comprises a prime moverand a drive wire adapted to be rotatably driven by the prime mover andeccentrically coupled to a distal end of a sheath of the laser energydelivery device, and wherein sending the signal to actuate the ancillarydevice in response to detecting transmission of laser energy through theat least one of the plurality of transport members comprises actuatingthe prime mover to rotate the drive wire and eccentrically rotate thedistal end of the sheath.

The non-transitory tangible computer-readable storage medium of any ofparagraphs [0025] to [0026], wherein sending the signal to actuate theprime mover to rotate the drive wire and eccentrically rotate the distalend of the sheath comprises: sending a first signal to actuate the primemover and rotate the drive wire and eccentrically rotate the distal endof the sheath in a first direction for a plurality of rotations; andsending a second signal to actuate the prime mover and rotate the drivewire and eccentrically rotate the distal end of the sheath in a seconddirection for a plurality of rotations, the second direction beingopposite the first direction.

The non-transitory tangible computer-readable storage medium of any ofparagraphs [0025] to [0027], wherein sending the signal to actuate theprime mover to rotate the drive wire and eccentrically rotate the distalend of the sheath comprises: sending a first signal to actuate the primemover and rotate the drive wire and eccentrically rotate the distal endof the sheath in a first direction; deactivating the prime mover toinhibit rotation of the drive wire and the distal end of the sheath whenthe distal end of the sheath reaches a first rotational limit; sending asecond signal to actuate the prime mover and rotate the drive wire andeccentrically rotate the distal end of the sheath in a second direction,the second direction being opposite the first direction; anddeactivating the prime mover to inhibit rotation of the drive wire andthe distal end of the sheath when the distal end of the sheath reaches asecond rotational limit.

The non-transitory tangible computer-readable storage medium of any ofparagraphs [0025] to [0028], wherein the method further includes:detecting a rotational position of the distal end of the sheath anddetermining when the distal end reaches a rotational limit; anddeactivating the prime mover to inhibit rotation of the drive wire andthe distal end when the distal end reaches the rotational limit.

The non-transitory tangible computer-readable storage medium of any ofparagraphs [0025] to [0029], wherein the method further includes sendinga second signal to actuate the prime mover and eccentrically rotate thedistal tip of the sheath to a rotational home position.

A method in accordance with this disclosure for treating a subject byusing a laser energy delivery device, the laser energy delivery deviceincluding a sheath, a plurality of transport members carried by thesheath, a sensor, and an ancillary device, may include positioning adistal end of the sheath within the subject such that the plurality oftransport members are positioned within the subject; transmitting laserenergy to the subject via the plurality of transport members; detectingtransmission of laser energy through at least one of the plurality oftransport members by using the sensor; and actuating the ancillarydevice in response to detecting transmission of laser energy through theat least one of the plurality of transport members.

The method of paragraph [0031], wherein the ancillary device includes aprime mover and a drive wire adapted to be rotatably driven by the primemover and eccentrically coupled to the distal end of the sheath, andwherein actuating the ancillary device in response to detectingtransmission of laser energy through the at least one of the pluralityof transport members includes actuating the prime mover to rotate thedrive wire and eccentrically rotate the distal end of the sheath.

The method of any of paragraphs [0031] to [0032], wherein actuating theprime mover to rotate the drive wire and eccentrically rotate the distalend of the sheath includes rotating the drive wire and eccentricallyrotating the distal end of the sheath in a first direction for aplurality of rotations; and subsequently rotating the drive wire andeccentrically rotating the distal end of the sheath in a seconddirection for a plurality of rotations, the second direction beingopposite the first direction.

The method of any of paragraphs [0031] to [0033], wherein transmittinglaser energy to the subject via the plurality of transport membersincludes transmitting laser energy from a proximal end of the pluralityof transport members to a distal end of the plurality of transportmembers, and detecting transmission of laser energy through the at leastone of the plurality of transport members includes detectingtransmission of laser energy at a location on the at least one of theplurality of transport members disposed between the proximal end and thedistal end of the plurality of transport members.

The method of any of paragraphs [0031] to [0034], wherein detectingtransmission of laser energy at the location on the at least one of theplurality of transport members disposed between the proximal end and thedistal end includes detecting emission of laser energy from a bendformed on the at least one of the plurality of transport members betweenthe proximal end and the distal end.

The method of any of paragraphs [0031] to [0035], wherein the sensorincludes a photodiode, and detecting transmission of laser energythrough the at least one of the plurality of transport members includesusing the photodiode to detect laser energy emitted from the at leastone of the plurality of transport members.

A method in accordance with this disclosure for treating a subject byusing a laser energy delivery device, the laser energy delivery deviceincluding a sheath and a plurality of transport members carried by thesheath, may include positioning the sheath within the subject such thata distal end of the plurality of transport members are positioned withinthe subject; receiving laser energy at a proximal end of the pluralityof transport members; transmitting laser energy from the proximal end tothe distal end of the plurality of transport members; delivering laserenergy from the distal end of the plurality of transport members to thesubject; and detecting emission of laser energy from at least one of theplurality of transport members at a location between the proximal endand the distal end of the plurality of transport members.

The method of paragraph [0037], wherein detecting emission of laserenergy from the at least one of the plurality of transport members atthe location between the proximal end and the distal end of theplurality of transport members includes detecting emission of laserenergy from a bend formed on the at least one of the plurality oftransport members between the proximal end and the distal end.

The method of any of paragraphs [0037] to [0038], wherein detectingemission of laser energy from the bend formed on the at least one of theplurality of transport members between the proximal end and the distalend includes using a photodiode to detect laser energy emitted from theat least one of the plurality of transport members.

The method of any of paragraphs [0037] to [0039], wherein the laserenergy delivery device further includes an ancillary device, and furtherincluding actuating the ancillary device in response to detectingemission of laser energy from the bend formed on the at least one of theplurality of transport members.

The method of any of paragraphs [0037] to [0040], wherein the laserenergy delivery device further includes a prime mover and a drive wireadapted to be rotatably driven by the prime mover and eccentricallycoupled to a distal end of the sheath, and further including actuatingthe prime mover to rotate the drive wire and eccentrically rotate thedistal end of the sheath in response to detecting emission of laserenergy from the at least one of the plurality of transport members.

The method of any of paragraphs [0037] to [0041], wherein actuating theprime mover to rotate the drive wire and eccentrically rotate the distalend of the sheath includes rotating the drive wire and eccentricallyrotating the distal end of the sheath in a first direction for aplurality of rotations, and subsequently rotating the drive wire andeccentrically rotating the distal end of the sheath in a seconddirection for a plurality of rotations, the second direction beingopposite the first direction.

A laser energy delivery device in accordance with this disclosure forproviding treatment to a subject may include a sheath including a distalend adapted to be disposed in the subject, a plurality of transportmembers carried by the sheath, the plurality of transport membersadapted to receive laser energy, transmit laser energy through thesheath, and deliver laser energy to the subject, a sensor adapted tosend a signal in response to detecting transmission of laser energythrough at least one of the plurality of transport members, a controlleradapted to receive the signal from the sensor, a prime mover adapted tobe actuated by the controller, and a drive wire eccentrically coupled tothe distal end of the sheath and adapted to be rotatably driven by theprime mover, the drive wire rotating to eccentrically rotate the distalend of the sheath, and wherein the controller actuates the prime moverto rotate the drive wire and eccentrically rotate the distal end of thesheath in response to receiving the signal from the sensor.

The laser energy delivery device of paragraph [0043], wherein the laserenergy delivery device is operable in an automatic mode and a manualmode, in the automatic mode the controller actuating the prime mover torotate the drive wire and eccentrically rotate the distal end of thesheath in response to receiving the signal from the sensor, and in themanual mode the controller actuating the prime mover to rotate the drivewire and eccentrically rotate the distal end of the sheath regardless ofwhether the controller receives the signal from the sensor.

The laser energy delivery device of any of paragraphs [0043] to [0044],further including a first input being actuatable by a clinician to placethe laser energy delivery device in the automatic mode, a second inputbeing actuatable by the clinician to cause the controller to actuate theprime mover to rotate the drive wire and eccentrically rotate the distalend of the sheath in a first direction regardless of whether thecontroller receives the signal from the sensor, and a third input beingactuatable by the clinician to cause the controller to actuate the primemover to rotate the drive wire and eccentrically rotate the distal endof the sheath in a second direction regardless of whether the controllerreceives the signal from the sensor, the second direction being oppositethe first direction.

The laser energy delivery device of any of paragraphs [0043] to [0045],further including a fourth input being actuatable by the clinician torotate the drive wire and eccentrically rotate the distal tip of thesheath to a rotational home position.

The laser energy delivery device of any of paragraphs [0043] to [0046],wherein in the automatic mode the controller actuates the prime mover torotate the drive wire and eccentrically rotate the distal end of thesheath in a first direction for a plurality of rotations, andsubsequently rotate the drive wire and eccentrically rotate the distalend of the sheath in a second direction for a plurality of rotations,the second direction being opposite the first direction.

The laser energy delivery device of any of paragraphs [0043] to [0047],wherein the drive wire rotates and the distal end of the sheatheccentrically rotates in a first direction and a second direction, thesecond direction being opposite the first direction, the controller isadapted to deactivate the prime mover when the drive wire and the distalend of the sheath rotate in the first direction and reach a firstrotational limit, and the controller is adapted to deactivate the primemover when the drive wire and the distal end of the sheath rotate in thesecond direction and reach a second rotational limit.

The laser energy delivery device of any of paragraphs [0043] to[0048],wherein the plurality of transport members include proximal ends adaptedto receive laser energy and distal ends adapted to deliver laser energyto the subject, and the sensor detects transmission of laser energythrough the at least one of the plurality of transport members at aposition between the proximal ends and the distal ends of the pluralityof transport members.

A method in accordance with this disclosure for treating a subject byusing a laser energy delivery device, the laser energy delivery devicecomprising a sheath having a distal end, a plurality of transportmembers carried by the sheath, a prime mover, a drive wire coupled tothe prime mover and eccentrically coupled to the distal end of thesheath, a sensor, and a controller operably coupled to the sensor andthe prime mover, may include positioning the distal end of the sheathwithin the subject such that the plurality of transport members arepositioned within the subject; transmitting laser energy to the subjectvia the plurality of transport members; detecting transmission of laserenergy through at least one of the plurality of transport members byusing the sensor; sending a signal from the sensor to the controller inresponse to detecting transmission of laser energy through the at leastone of the plurality of transport members; and actuating the primemover, via the controller, to rotate the drive wire and eccentricallyrotate the distal end of the sheath in response to the controllerreceiving the signal from the sensor.

The method of paragraph [0050], further including operating the laserenergy delivery device in an automatic mode, including: detectingtransmission of laser energy through the at least one of the pluralityof transport members by using the sensor; sending the signal from thesensor to the controller in response to detecting transmission of laserenergy through the at least one of the plurality of transport members;actuating the prime mover, via the controller, to rotate the drive wireand eccentrically rotate the distal end of the sheath in response to thecontroller receiving the signal from the sensor; and operating the laserenergy delivery device in a manual mode, including: actuating an inputof the laser energy delivery device; and actuating the prime mover, viathe controller, to rotate the drive wire and eccentrically rotate thedistal end of the sheath in response to actuating the input of the laserenergy delivery device.

The method of any of paragraphs [0050] to [0051], wherein the input is afirst input, and operating the laser energy delivery device in themanual mode further includes: actuating the first input of the laserenergy delivery device; actuating the prime mover, via the controller,to rotate the drive wire and eccentrically rotate the distal end of thesheath in a first direction in response to actuating the first input ofthe laser energy delivery device; actuating a second input of the laserenergy delivery device; and actuating the prime mover, via thecontroller, to rotate the drive wire and eccentrically rotate the distalend of the sheath in a second direction in response to actuating thesecond input of the laser energy delivery device, the second directionbeing opposite the first direction.

The method of any of paragraphs [0050] to [0052], wherein operating thelaser energy delivery device in the manual mode further includesdeactivating the prime mover, via the controller, to inhibit rotation ofthe drive wire and the distal end of the sheath when the distal end ofthe sheath reaches a rotational limit.

The method of any of paragraphs [0050] to [0053], wherein actuating theprime mover includes actuating the prime mover, via the controller, torotate the drive wire and eccentrically rotate the distal end of thesheath in a first direction in response to the controller receiving thesignal from the sensor, and further including: deactivating the primemover, via the controller, to inhibit rotation of the drive wire and thedistal end of the sheath in the first direction when the distal end ofthe sheath reaches a rotational limit; and actuating the prime mover,via the controller, to rotate the drive wire and eccentrically rotatethe distal end of the sheath in a second direction in response to thedistal end of the sheath reaching the rotational limit, the seconddirection being opposite the first direction.

The method of any of paragraphs [0050] to [0054], wherein the rotationallimit is a first rotational limit, and further including: deactivatingthe prime mover, via the controller, to inhibit rotation of the drivewire and the distal end of the sheath in the second direction when thedistal end of the sheath reaches a second rotational limit; andactuating the prime mover, via the controller, to rotate the drive wireand eccentrically rotate the distal end of the sheath in the firstdirection in response to the distal end of the sheath reaching thesecond rotational limit.

A laser energy delivery device in accordance with this disclosure forproviding treatment to a subject may include a housing, a couplingcarried by the housing and adapted to couple to a laser energygenerator, a sheath carried by the housing, the sheath including adistal end adapted to be disposed in the subject, a plurality oftransport members carried by the sheath, the plurality of transportmembers adapted to receive laser energy at the coupling, transmit laserenergy through the sheath, and deliver laser energy to the subject, afluid-driven motor carried by the housing and adapted to be driven uponreceiving a fluid from a fluid source, and a drive wire carried by thesheath and eccentrically coupled to the distal end of the sheath, thedrive wire adapted to be rotatably driven by the fluid-driven motor androtating to eccentrically rotate the distal end of the sheath.

The laser energy delivery device of paragraph [0056], wherein thefluid-driven motor includes a first inlet/outlet port and a secondinlet/outlet port, the fluid-driven motor is adapted to receive thefluid via the first inlet/outlet port and discharge the fluid via thesecond inlet/outlet port to rotate the fluid-driven motor and the drivewire in a first direction, the fluid-driven motor is adapted to receivethe fluid via the second inlet/outlet port and discharge the fluid viathe first inlet/outlet port to rotate the fluid-driven motor and thedrive wire in a second direction opposite the first direction.

The laser energy delivery device of any of paragraphs [0056] to [0057],further including a directional control valve coupled to thefluid-driven motor, the directional control valve being adapted toselectively deliver the fluid to the first inlet/outlet port and thesecond inlet/outlet port of the fluid-driven motor to rotate the drivewire in the first direction and the second direction, respectively.

The laser energy delivery device of any of paragraphs [0056] to [0058],further including a controller operatively coupled to the directionalcontrol valve to selectively deliver the fluid to the first inlet/outletport and the second inlet/outlet port of the fluid-driven motor torotate the drive wire in the first direction and the second direction,respectively.

The laser energy delivery device of any of paragraphs [0056] to [0059],further including a plurality of visual indicators carried by thehousing, wherein the controller is adapted to energize the plurality ofvisual indicators based on a rotational position of the fluid-drivenmotor relative to the housing.

The laser energy delivery device of any of paragraphs [0056] to [0060],further including a sensor adapted to detect transmission of laserenergy through at least one of the plurality of transport members.

The laser energy delivery device of any of paragraphs [0056] to [0061],wherein the sensor is adapted to send a signal in response to detectingtransmission of laser energy through the at least one of the pluralityof transport members, wherein the controller is adapted to receive thesignal from the sensor, and further including an ancillary deviceadapted to augment treatment of the subject via the laser energydelivery device, the controller actuating the ancillary device uponreceiving the signal from the sensor.

The laser energy delivery device of any of paragraphs [0056] to [0062],wherein the ancillary device includes: the fluid-driven motor; and thedrive wire.

The laser energy delivery device of any of paragraphs [0056] to [0063],wherein the directional control valve is a four-way valve.

The laser energy delivery device of any of paragraphs [0056] to [0064],further including a speed reducer coupling the fluid-driven motor to thedrive wire.

The laser energy delivery device of any of paragraphs [0056] to [0065],wherein the speed reducer is a gearbox.

The laser energy delivery device of any of paragraphs [0056] to [0066],further including: a controller carried by the housing; and a pluralityof visual indicators carried by the housing, wherein the controller isadapted to energize the plurality of visual indicators based on arotational position of the fluid-driven motor relative to the housing.

The laser energy delivery device of any of paragraphs [0056] to [0067],wherein the controller is adapted to energize at least one of the visualindicators when the rotational position of the fluid-driven motorreaches a threshold.

The laser energy delivery device of any of paragraphs [0056] to [0068],wherein each visual indicator of the plurality of visual indicatorscorresponds to a portion of a rotational range of the fluid-drivenmotor, and wherein the controller is adapted to energize each visualindicator when the rotational position of the fluid-driven motor iswithin the portion of the rotational range of each visual indicator.

The laser energy delivery device of any of paragraphs [0056] to [0069],further including a sensor adapted to detect transmission of laserenergy through at least one of the plurality of transport members.

The laser energy delivery device of any of paragraphs [0056] to [0070],wherein the sensor is adapted to send a signal in response to detectingtransmission of laser energy through the at least one of the pluralityof transport members, wherein the controller is adapted to receive thesignal from the sensor, and further including an ancillary deviceadapted to augment treatment of the subject via the laser energydelivery device, the controller actuating the ancillary device uponreceiving the signal from the sensor.

The laser energy delivery device of any of paragraphs [0056] to [0071],wherein the ancillary device includes: the fluid-driven motor; and thedrive wire.

The laser energy delivery device of any of paragraphs [0056] to [0072],wherein the at least one of the plurality of transport members extendsfrom a proximal end to a distal end, and the sensor is adapted to detectemission of laser energy at a location on the at least one of theplurality of transport members disposed between the proximal end and thedistal end.

The laser energy delivery device of any of paragraphs [0056] to [0073],wherein the at least one of the plurality of transport members includesa bend formed between the proximal end and the distal end, and thesensor is adapted to detect emission of laser energy at the bend.

A laser ablation catheter in accordance with this disclosure includes adistal tip including: a body defining a longitudinal axis; a firstorientation indicator formed on the body; a second orientation indicatorformed on the body, the second orientation indicator disposed relativeto the first orientation indicator such that when the distal tip isviewed in a first side view, the second orientation indicator and thefirst orientation indicator overlap and visually contrast with the body;a third orientation indicator formed on the body, the third orientationindicator disposed relative to the second orientation indicator suchthat when the distal tip is viewed in a second side view, the thirdorientation indicator and the second orientation indicator overlap andvisually contrast with the body, the second side view and the first sideview being substantially 90 degrees apart about the longitudinal axis; aplurality of transport members carried by the distal tip and disposed inan eccentric arrangement relative to the longitudinal axis, theplurality of transport members adapted to transmit laser energy.

The laser ablation catheter of paragraph [0075], further including aguide wire lumen eccentrically carried by the body.

The laser ablation catheter of any of paragraphs [0075] to [0076],wherein the body further defines: a first axial plane along which thelongitudinal axis extends, the first axial plane bisecting the guidewire lumen; and a second axial plane along which the longitudinal axisextends; the second axial plane being perpendicular to the first axialplane; wherein the guide wire lumen is at least partially disposed on afirst side of the second axial plane, and a majority of the transportmembers are disposed on a second side of the second axial plane, thesecond side being opposite the first side.

The laser ablation catheter of any of paragraphs [0075] to [0077],wherein the first orientation indicator and the second orientationindicator are disposed on the second side of the second axial plane.

The laser ablation catheter of any of paragraphs [0075] to [0078],wherein the second orientation indictor is disposed on the second sideof the second axial plane and the third orientation indictor is disposedon the first side of the second axial plane.

The laser ablation catheter of any of paragraphs [0075] to [0079],wherein the body obscures the third orientation indicator when thedistal tip is viewed in the first side view.

The laser ablation catheter of any of paragraphs [0075] to [0080],wherein the body obscures the first orientation indicator when thedistal tip is viewed in the second side view via medical imaging.

The laser ablation catheter of any of paragraphs [0075] to [0081],wherein each of the first orientation indicator, the second orientationindicator, and the third orientation indicator are symmetric over atransverse plane, the transverse plane being substantially perpendicularto the longitudinal axis.

The laser ablation catheter of any of paragraphs [0075] to [0082],wherein each of the first orientation indicator, the second orientationindicator, and the third orientation indicator have a triangular shape.

The laser ablation catheter of any of paragraphs [0075] to [0083],wherein the first orientation indicator tapers in a circumferentialdirection along an outer surface of the distal tip, the firstorientation indicator tapering from a first width to a second width, thesecond width being less than the first width.

The laser ablation catheter of any of paragraphs [0075] to [0084],wherein the first width is disposed between the second width and thelongitudinal axis when the distal tip is viewed in the first side view.

The laser ablation catheter of any of paragraphs [0075] to [0085],wherein the second orientation indicator tapers in a circumferentialdirection along an outer surface of the distal tip, the secondorientation indicator tapering from a first width to a second width, thesecond width being less than the first width.

The laser ablation catheter of any of paragraphs [0075] to [0086],wherein the second width is disposed between the first width and thelongitudinal axis when the distal tip is viewed in the second side view.

The laser ablation catheter of any of paragraphs [0075] to [0087],wherein, when the distal tip is viewed in the first side view, thesecond orientation indicator and the first orientation indicator overlapand visually contrast with the body by appearing as a shape having afirst size, and when the distal tip is viewed in a first intermediateside view between the first side view and the second side view about thelongitudinal axis, the second orientation indicator and the firstorientation indicator overlap and visually contrast with the body byappearing as the shape having a second size, the second size being lessthan the first size.

The laser ablation catheter of any of paragraphs [0075] to [0088],wherein the first orientation indicator has a first surface area on anouter surface of the distal tip, the second orientation indicator has asecond surface area on the outer surface of the distal tip, and thesecond surface area is substantially equal to the first surface area.

The laser ablation catheter of any of paragraphs [0075] to [0089],wherein the third orientation indicator has a third surface area on theouter surface of the distal tip, and the third surface area is less thanthe first surface area.

The laser ablation catheter of any of paragraphs [0075] to [0090],wherein each of the first orientation indicator, the second orientationindicator, and the third orientation indicator are formed as openings onthe body.

The laser ablation catheter of any of paragraphs [0075] to [0091],further including a drive wire eccentrically carried by the body, thedrive wire being rotatable to eccentrically rotate the distal tiprelative to the longitudinal axis.

The laser ablation catheter of any of paragraphs [0075] to [0092],wherein the first orientation indicator, the second orientationindicator, and the third orientation indicator are radiopaque and thebody is radiolucent.

The laser ablation catheter of any of paragraphs [0075] to [0093],wherein the first orientation indicator, the second orientationindicator, and the third orientation indicator have a first radiopacity,the body has a second radiopacity, and the first radiopacity isdifferent than the second radiopacity.

A laser ablation catheter in accordance with this disclosure includes adistal tip including: a body defining a longitudinal axis; a firstorientation indicator formed on the body, the first orientationindicator having an alphanumeric shape; a second orientation indicatorformed on the body, the second orientation indicator disposed relativeto the first orientation indicator such that when the distal tip isviewed in a first side view, the second orientation indicator and thefirst orientation indicator overlap, appear as the alphanumeric shape,and visually contrast with the body, and the second orientationindicator configured such that when the distal tip is viewed in a secondside view, the second orientation indicator appears as the alphanumericshape and visually contrasts with the body, the second side view and thefirst side view being substantially 90 degrees apart about thelongitudinal axis; a plurality of transport members carried by thedistal tip and disposed in an eccentric arrangement relative to thelongitudinal axis, the plurality of transport members adapted totransmit laser energy.

The laser ablation catheter of paragraph [0095], wherein the distal tipfurther includes a guide wire lumen eccentrically disposed relative tothe longitudinal axis.

The laser ablation catheter of any of paragraphs [0095] to [0096],wherein the body further defines: a first axial plane along which thelongitudinal axis extends, the first axial plane bisecting the guidewire lumen; and a second axial plane along which the longitudinal axisextends; the second axial plane being perpendicular to the first axialplane; wherein the guide wire lumen is at least partially disposed on afirst side of the second axial plane, and a majority of the transportmembers are disposed on a second side of the second axial plane, thesecond side being opposite the first side.

The laser ablation catheter of any of paragraphs [0095] to [0097],wherein the first orientation indicator is disposed on the second sideof the second axial plane and the second orientation indicator isbisected by the second axial plane.

The laser ablation catheter of any of paragraphs [0095] to [0098],wherein the body obscures the first orientation indicator when thedistal tip is viewed in the second side view via medical imaging.

The laser ablation catheter of any of paragraphs [0095] to [0099],wherein the first orientation indicator and the second orientationindicator are asymmetric over a transverse plane, the transverse planebeing substantially perpendicular to the longitudinal axis.

The laser ablation catheter of any of paragraphs [0095] to [00100],wherein the alphanumeric shape is an L-shape.

The laser ablation catheter of any of paragraphs [0095] to [00101],wherein the first orientation indicator is formed as an opening on thebody, and the second orientation indicator is formed as a channel formedon the body.

The laser ablation catheter of any of paragraphs [0095] to [00102],wherein the body further includes a transport member opening in whichthe plurality of transport members are carried, the first orientationindicator and the second orientation indicator in communication with thetransport member opening.

The laser ablation catheter of any of paragraphs [0095] to [00103],wherein the distal tip further includes a radiolucent material carriedin the transport member opening, the first orientation indicator, andthe second orientation indicator.

The laser ablation catheter of any of paragraphs [0095] to [00104],wherein the alphanumeric shape has a first area when the distal tip isviewed in the first side view, the alphanumeric shape has a second areawhen the distal tip is viewed in the second side view, and the secondarea is different than the first area.

The laser ablation catheter of any of paragraphs [0095] to [00105],wherein the second area is less than the first area.

The laser ablation catheter of any of paragraphs [0095] to [00106],wherein, when the distal tip is viewed in a first intermediate side viewbetween the first side view and the second side view about thelongitudinal axis, the second orientation indicator and the firstorientation indicator overlap and visually contrast with the body byappearing as a second shape, the second shape being different thealphanumeric shape.

The laser ablation catheter of any of paragraphs [0095] to [00107],wherein the second shape is a non-alphanumeric shape.

The laser ablation catheter of any of paragraphs [0095] to [00108],wherein alphanumeric shape is an asymmetric shape and the second shapeis a symmetric shape.

The laser ablation catheter of any of paragraphs [0095] to [00109],wherein alphanumeric shape is an L-shape and the second shape is arectangle.

A laser ablation catheter in accordance with this disclosure includes adistal tip including: a body including: a longitudinal axis; a guidewire lumen eccentrically disposed relative to the longitudinal axis; afirst axial plane along which the longitudinal axis extends, the firstaxial plane bisecting the guide wire lumen, and the body beingasymmetric over the first axial plane; a first orientation indicatorformed on the body, the first orientation indicator having an asymmetricshape; a second orientation indicator formed on the body, the secondorientation indicator disposed relative to the first orientationindicator such that when the distal tip is viewed in a first side view,the second orientation indicator and the first orientation indicatoroverlap, appear as the asymmetric shape, and visually contrast with thebody, and the second orientation indicator configured such that when thedistal tip is viewed in a second side view, the second orientationindicator appears as the asymmetric shape and visually contrasts withthe body, the second side view and the first side view beingsubstantially 90 degrees apart about the longitudinal axis; a pluralityof transport members carried by the distal tip and disposed in aneccentric arrangement relative to the longitudinal axis, the pluralityof transport members adapted to transmit laser energy.

The laser ablation catheter of paragraph [00111], wherein, when thedistal tip is viewed in a first intermediate side view between the firstside view and the second side view about the longitudinal axis, thesecond orientation indicator and the first orientation indicator overlapand visually contrast with the body by appearing as a second shape, thesecond shape being different the asymmetric shape.

The laser ablation catheter of any of paragraphs [00111] to [00112],wherein the second shape is a symmetric shape.

The laser ablation catheter of any of paragraphs [00111] to [00113],wherein the asymmetric shape has a first area when the distal tip isviewed in the first side view, the asymmetric shape has a second areawhen the distal tip is viewed in the second side view, and the secondarea is different than the first area.

The phrases “at least one”, “one or more”, and “and/or” are open-endedexpressions that are both conjunctive and disjunctive in operation. Forexample, each of the expressions “at least one of A, B and C”, “at leastone of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B,or C” and “A, B, and/or C” means A alone, B alone, C alone, A and Btogether, A and C together, B and C together, or A, B and C together.When each one of A, B, and C in the above expressions refers to anelement, such as X, Y, and Z, or class of elements, such as X₁-X_(n),Y₁-Y_(m), and Z₁-Z_(o), the phrase is intended to refer to a singleelement selected from X, Y, and Z, a combination of elements selectedfrom the same class (e.g., X₁ and X₂) as well as a combination ofelements selected from two or more classes (e.g., Y₁ and Z_(o)).

The term “a” or “an” entity refers to one or more of that entity. Assuch, the terms “a” (or “an”), “one or more” and “at least one” may beused interchangeably herein. It is also to be noted that the terms“comprising”, “including”, and “having” may be used interchangeably.

The phrase “fluid power” is the use of fluids, generally under pressure,to generate, control, and transmit power. Fluid power may be generatedby a pneumatics power system, which uses a gas such as air (e.g.,compressed air) or other gases to generate, control, and transmit power.Fluid power may also be generated by a hydraulic power system, whichuses a liquid such as water, saline, and oil (e.g., mineral oil) togenerate, control, and transmit power. For example, a fluid-driven motormay convert movement of fluid into mechanical power (energy) and/orelectrical power (energy).

It should be understood that every maximum numerical limitation giventhroughout this disclosure is deemed to include each and every lowernumerical limitation as an alternative, as if such lower numericallimitations were expressly written herein. Every minimum numericallimitation given throughout this disclosure is deemed to include eachand every higher numerical limitation as an alternative, as if suchhigher numerical limitations were expressly written herein. Everynumerical range given throughout this disclosure is deemed to includeeach and every narrower numerical range that falls within such broadernumerical range, as if such narrower numerical ranges were all expresslywritten herein.

The preceding is a simplified summary of the disclosure to provide anunderstanding of some aspects of the disclosure. This summary is neitheran extensive nor exhaustive overview of the disclosure and its variousaspects, embodiments, and configurations. It is intended neither toidentify key or critical elements of the disclosure nor to delineate thescope of the disclosure but to present selected concepts of thedisclosure in a simplified form as an introduction to the more detaileddescription presented below. As will be appreciated, other aspects,embodiments, and configurations of the disclosure are possibleutilizing, alone or in combination, one or more of the features setforth above or described in detail below.

The above and other features of the present disclosure, which alone orin any combination may comprise patentable subject matter, will becomeapparent from the following description and the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are incorporated into and form a part of thespecification to illustrate several examples of the present disclosure.These drawings, together with the description, explain the principles ofthe disclosure. The drawings simply illustrate preferred and alternativeexamples of how the disclosure may be made and used and are not to beconstrued as limiting the disclosure to only the illustrated anddescribed examples. Further features and advantages will become apparentfrom the following, more detailed, description of the various aspects,embodiments, and configurations of the disclosure, as illustrated by thedrawings referenced below.

FIG. 1 is a schematic illustration of an exemplary laser ablation systemfor use in ablating tissue in interventional procedures within thecardiovascular system of a subject;

FIG. 2 is another schematic illustration of the laser ablation system ofFIG. 1;

FIG. 3 is a schematic illustration of a clinician-operable foot switchof the laser ablation system of FIG. 1 in an undepressed state;

FIG. 4 is a schematic illustration of the clinician-operable foot switchof FIG. 3 in a depressed state;

FIG. 5 is a schematic illustration of a laser energy delivery device ofthe laser ablation system of FIG. 1;

FIG. 6 is an illustration of an exemplary control panel of the laserenergy delivery device of FIG. 5;

FIG. 7 illustrates an exemplary method for treating a subject by using alaser energy delivery device;

FIG. 8 is an illustration of an exemplary laser ablation catheter;

FIG. 9 is an illustration of an input coupling and a partialillustration of a flexible cord of the laser ablation catheter of FIG.8;

FIG. 10 is an illustration of a housing and a partial illustration ofthe flexible cord and a laser ablation catheter sheath of the laserablation catheter of FIG. 8;

FIG. 11 is an illustration of a base of the housing of FIG. 10 with acover of the housing removed;

FIG. 12 is an illustration of the cover of the housing of FIG. 10 withthe base of the housing removed;

FIG. 13 is a partial illustration of a trifurcate structure of the laserablation catheter of FIG. 8;

FIG. 14 is another partial illustration of the trifurcate structure ofFIG. 13;

FIG. 15 is an illustration of a control panel of the laser ablationcatheter of FIG. 8;

FIG. 16 is a partial illustration of the laser ablation catheter sheathof the laser ablation catheter of FIG. 8;

FIG. 17A is a cross-sectional illustration of the laser ablationcatheter sheath along line 17A-17A of FIG. 16;

FIG. 17B is a cross-sectional illustration of the laser ablationcatheter sheath along line 17B-17B of FIG. 16;

FIG. 17C is an end view illustration of the laser ablation cathetersheath along line 17C-17C of FIG. 16;

FIG. 17D is a side view illustration of a distal tip of the laserablation catheter sheath of FIG. 16;

FIGS. 18A-18E illustrate an exemplary process diagram for treating asubject by using a laser energy delivery device;

FIG. 19 is an illustration of an exemplary control panel of a laserablation catheter;

FIG. 20 is an illustration of another exemplary control panel of a laserablation catheter;

FIG. 21 is a circuit diagram of an exemplary laser ablation catheterincluding pneumatic components;

FIG. 22 is a circuit diagram of an exemplary laser ablation catheterincluding hydraulic components; and

FIG. 23 is a circuit diagram of another exemplary laser ablationcatheter including hydraulic components.

FIG. 24 is an end view illustration of a laser ablation catheter sheathof an exemplary laser ablation catheter.

FIG. 25A is a perspective view illustration of a distal tip of the laserablation catheter sheath of FIG. 24.

FIG. 25B is a top view illustration of the distal tip of FIG. 25A.

FIG. 25C is a left side view illustration of the distal tip of FIG. 25A.

FIG. 25D is an end view illustration of the distal tip of FIG. 25A.

FIG. 25E is a right side view illustration of the distal tip of FIG.25A.

FIG. 25F is a bottom view illustration of the distal tip of FIG. 25A.

FIG. 26A is a first side view illustration of the distal tip of FIG.25A, a drive wire, and a guide wire under medical imaging.

FIG. 26B is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 26A.

FIG. 26C is a second side view illustration of the distal tip of FIG.25A, the drive wire, and the guide wire under medical imaging.

FIG. 26D is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 26C.

FIG. 26E is a third side view illustration of the distal tip of FIG.25A, the drive wire, and the guide wire under medical imaging.

FIG. 26F is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 26E.

FIG. 26G is a fourth side view illustration of the distal tip of FIG.25A, the drive wire, and the guide wire under medical imaging.

FIG. 26H is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 26G.

FIG. 26I is a first intermediate side view illustration of the distaltip of FIG. 25A, the drive wire, and the guide wire under medicalimaging.

FIG. 26J is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 26I.

FIG. 27 is an end view illustration of a laser ablation catheter sheathof another exemplary laser ablation catheter.

FIG. 28A is a perspective view illustration of a distal tip of the laserablation catheter sheath of FIG. 27.

FIG. 28B is a top view illustration of the distal tip of FIG. 28A.

FIG. 28C is a left side view illustration of the distal tip of FIG. 28A.

FIG. 28D is an end view illustration of the distal tip of FIG. 28A.

FIG. 28E is a right side view illustration of the distal tip of FIG.28A.

FIG. 28F is a bottom view illustration of the distal tip of FIG. 28A.

FIG. 29A is a first side view illustration of the distal tip of FIG.28A, a drive wire, and a guide wire under medical imaging.

FIG. 29B is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 29A.

FIG. 29C is a second side view illustration of the distal tip of FIG.28A, the drive wire, and the guide wire under medical imaging.

FIG. 29D is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 29C.

FIG. 29E is a third side view illustration of the distal tip of FIG.28A, the drive wire, and the guide wire under medical imaging.

FIG. 29F is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 29E.

FIG. 29G is a fourth side view illustration of the distal tip of FIG.28A, the drive wire, and the guide wire under medical imaging.

FIG. 29H is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 29G.

FIG. 29I is a first intermediate side view illustration of the distaltip of FIG. 28A, the drive wire, and the guide wire under medicalimaging.

FIG. 29J is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 29I.

FIG. 29K is a first intermediate side view illustration of the distaltip of FIG. 28A, the drive wire, and the guide wire under medicalimaging.

FIG. 29L is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 29K.

FIG. 29M is a first intermediate side view illustration of the distaltip of FIG. 28A, the drive wire, and the guide wire under medicalimaging.

FIG. 29N is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 29M.

FIG. 29O is a first intermediate side view illustration of the distaltip of FIG. 28A, the drive wire, and the guide wire under medicalimaging.

FIG. 29P is an end view illustration of the distal tip, the drive wire,and the guide wire in the same orientation as FIG. 29O.

Corresponding reference characters indicate corresponding partsthroughout the several views. It should be understood that the drawingsare not necessarily to scale. In certain instances, details that are notnecessary for an understanding of the disclosure or that render otherdetails difficult to perceive may have been omitted. It should beunderstood, of course, that the disclosure is not necessarily limited tothe particular embodiments illustrated herein.

DETAILED DESCRIPTION OF THE DRAWINGS

Before any embodiments of the disclosure are explained in detail, it isto be understood that the disclosure is not limited in its applicationto the details of construction and the arrangement of components setforth in the following description or illustrated in the followingdrawings. The disclosure is capable of other embodiments and of beingpracticed or of being carried out in various ways. Also, it is to beunderstood that the phraseology and terminology used herein is for thepurpose of description and should not be regarded as limiting. The useof “including,” “comprising,” or “having” and variations thereof hereinis meant to encompass the items listed thereafter and equivalentsthereof as well as additional items.

The embodiments disclosed below are not intended to be exhaustive or tolimit the invention to the precise forms disclosed in the followingdetailed description. Rather, the embodiments are chosen and describedso that others skilled in the art may utilize their teachings.

FIGS. 1 and 2 illustrate an exemplary laser ablation system 100. Thelaser ablation system 100 generally includes a laser energy generator or“base unit” 102 that generates laser energy, a switch unit 104 that isoperable to actuate the base unit 102, and a laser energy deliverydevice 106 that delivers laser energy to ablate tissue of a subject.

The base unit 102 includes a housing 105. The housing 105 carries alaser 108 and a base electronic controller 110 that is operativelycoupled to the laser 108. The base controller 110 controls operation ofthe laser 108 and communication of laser energy produced by laser 108 toan output coupling 112 of the base unit 102. As shown in FIG. 2, thehousing 105 also carries a plurality of wheels 114 that facilitatemovement of the base unit 102. The housing 105 further carries aclinician-operable control panel 116 that is operatively coupled to thebase controller 110. The control panel 116 facilitates setting and/orvarying operating parameters of the base unit 102.

The base unit 102 may be, for example, the CVX-300 Excimer Laser Systemavailable from The Spectranetics Corporation, Colorado Springs, Colo.The base unit 102 may be, for example, as described in U.S. Pat. No.5,383,199, the entire disclosure of which is expressly incorporated byreference herein for all purposes.

The switch unit 104 includes a switch electronic controller 118 and aclinician-operable switch 120. The clinician-operable switch 120receives an input from a clinician. Exemplary clinician-operableswitches include toggle switches, foot-operated pedal switches, rotaryswitches, input switches, and other devices via which a clinician canprovide an input.

The switch unit 104 is coupled to base unit 102 via a tether 122. Afirst end of the tether 122 is coupled to the base unit 102 and a secondend of the tether 122 is coupled to the switch unit 104. The tether 122keeps the switch unit 104 within an area surrounding base unit 102 andinhibits the switch unit 104 from being separated from the base unit102. In some embodiments, the switch unit 104 may be stored within acompartment of the base unit 102 when not in use and positioned remotefrom the base unit 102 during use of the laser ablation system 100. Inthese embodiments, the first end of the tether 122 is anchored inside ofthe storage compartment of the base unit 102. In some embodiments, thetether 122 lacks any power lines and/or communication lines. In theseembodiments, the switch unit 104 may include a power supply (not shown)and wirelessly communicate with the base unit 102. In some embodiments,the tether 122 includes one or more power lines and/or communicationlines. An exemplary tether is a jacketed, flexible, steel wire safetycable. Other exemplary tethers include ropes, wires, and other flexiblemembers.

As described briefly above, the switch unit 104 may be a foot-operatedpedal switch. FIGS. 3 and 4 illustrate an exemplary foot-operated pedalswitch 300. The pedal switch 300 includes a base 302, a pedal 304 thatis moveably coupled to the base 302, and a switch 306 that provides anindication of the position of the pedal 304 relative to the base 302. Asshown in FIG. 3, the pedal 304 is rotated upward relative to the base302. As shown in FIG. 4, the pedal 304 is rotated downward relative tobase 302. In some embodiments, the pedal 304 may be biased to theposition shown in FIG. 3 (that is, rotated upward relative to the base302) by one or more springs (not shown).

The base 302 carries a first contact 308, and the pedal 304 carries asecond contact 310. When the contacts 308 and 310 are in contact (seeFIG. 4), the pedal switch 300 is in a first state. When the contacts 308and 310 are spaced apart (see FIG. 3), the pedal switch 300 is in asecond state. The switch controller 118 monitors whether the pedalswitch 300 is in the first state or the second state. For example, theopening or closing of the pedal switch 300 may change an input voltageto the switch controller 118. A clinician may press down on the pedal304 to engage the contacts 308 and 310, which causes the switch unit 104to actuate the base unit 102 and deliver laser energy to the laserenergy delivery device 106. In some embodiments, engaging the contacts308 and 310 causes the base unit 102 to deliver a series of laser energypulses to the laser energy delivery device 106. The clinician mayrelease the pedal 304 to disengage the contacts 308 and 310, whichinhibits the base unit 102 from delivering laser energy to the laserenergy delivery device 106.

The laser energy delivery device 106 may be a laser ablation catheter.FIG. 5 illustrates an exemplary laser ablation catheter 500. The laserablation catheter 500 includes an input coupling 502 that couples to theoutput coupling 112 of the base unit 102. The laser ablation catheter500 includes one or more transport members 504, such as fiber opticcables. The proximal ends 505 of the transport members 504 are disposedat the input coupling 502 and receive laser energy from the base unit102. The transport members 504 transmit laser energy from the proximalends 505, through a housing 503 of the laser ablation catheter 500, andto their distal ends 506, which may be disposed at a distal end 509 of asheath 507 of the laser ablation catheter 500. When the laser energyreaches the distal ends 506 of the transport members 504, the transportmembers 504 deliver the laser energy to the environment surrounding thesheath 507 (for example, tissue of the subject).

The laser ablation catheter 500 also includes one or more ancillarydevices 508 that augment tissue ablation. The ancillary devices 508 maybe carried by the housing 503 and may include, for example, a drivemechanism for translating the laser ablation catheter 500 in thevasculature of the subject, a drive mechanism for rotating the laserablation catheter 500 in the vasculature of the subject, or anaspiration mechanism for drawing ablated tissue through the laserablation catheter 500. In some embodiments, the ancillary devices 508augment tissue ablation by momentarily, instantaneously, andcontinuously calibrating and adjusting delivered laser energy. In someembodiments, the ancillary devices 508 augment tissue ablation bymonitoring the status of the laser ablation catheter 500 and/or the baseunit 102. In some embodiments, the ancillary devices 508 may deactivatethe laser ablation catheter 500 and/or the base unit 102 upon detectinga malfunction. The laser ablation catheter 500 further includescomponents for automatically actuating the ancillary device(s) 508 whenlaser energy is transmitted through the transport members 504. In someembodiments, the laser ablation catheter 500 includes a sensor 510 thatis carried by the housing 503. In some embodiments, the sensor 510includes a photodiode that detects a relatively small amount of laserenergy that is emitted, or “leaked”, at a curve or bend 512 in one ormore of the transport members 504 when laser energy is transmittedthrough the transport member(s) 504. The sensor 510 may detect variouswavelengths or various ranges of wavelengths of emitted laser energy.When the sensor 510 detects emitted laser energy at the bend 512 in thetransport member(s) 504, the sensor 510 transmits a signal to a catheterelectronic controller 514. In some embodiments, the catheter controller514 is carried by the housing 503. In some embodiments, the cathetercontroller 514 is formed by one or more circuits board. Upon receivingthe signal from the sensor 510, the catheter controller 514 actuates theancillary device(s) 508. In some embodiments, the catheter controller514 delivers energy from a power supply 516, such as a battery, to theancillary device(s) 508 to actuate the ancillary device(s) 508. In someembodiments, the power supply 516 is carried by the housing 503.

In some embodiments, the catheter controller 514 actuates the ancillarydevice(s) 508 only when the sensor 510 detects emitted laser energy atthe bend 512 (for example, by delivering energy from the power supply516 to the ancillary device(s) 508). When the sensor 510 does not detectemitted laser energy at the bend 512, the catheter controller 514deactivates the ancillary device(s) 508 (for example, the cathetercontroller 514 stops delivering energy from the power supply 516 to theancillary device(s) 508).

In some embodiments, the catheter controller 514 continuously actuatesthe ancillary device(s) 508 when the sensor 510 detects a series ofemitted laser energy pulses at the bend 512 (for example, by deliveringenergy from the power supply 516 to the ancillary device(s) 508). Whenthe sensor 510 does not detect emitted laser energy at the bend 512 fora time period that is longer than the time period between laser energypulses, the catheter controller 514 deactivates the ancillary device(s)508 (for example, the catheter controller 514 stops delivering energyfrom the power supply 516 to the ancillary device(s) 508).

In some embodiments, the catheter controller 514 actuates the ancillarydevice(s) 508 for a predetermined time period after the sensor 510detects emitted laser energy at the bend 512 (for example, by deliveringenergy from the power supply 516 to the ancillary device(s) 508). Afterthe predetermined time period elapses, the catheter controller 514deactivates the ancillary device(s) 508 (for example, the cathetercontroller 514 stops delivering energy from the power supply 516 to theancillary device(s) 508).

The bend 512 formed by the transport member(s) 504 may take a variety ofshapes and forms. For example, the bend 512 could be formed as one ormore turns, loops, or coils of the transport member(s) 504. In someembodiments, the transport members 504 lack any bends 512 and the sensor510 detects emitted laser energy along a straight portion of one or moreof the transport members 504. In some embodiments, the transport members504 lack any bends 512 and one or more of the transport members 504terminate before extending into the sheath 507 of the laser ablationcatheter 500. These transport member(s) 504 do not deliver laser energyto ablate tissue of the subject. Instead, these transport member(s) 504deliver laser energy to the sensor 510 to facilitate actuation of theancillary device(s) 508.

In some embodiments, the portion of the transport member(s) 504 thatemits laser energy toward the sensor 510 includes a buffer, coating,sheath, sticker, or patch that facilitates indirect detection of emittedlaser energy by the sensor 510. For example, the transport member(s) 504may include a coating that fluoresces when exposed to laser energy, andthe sensor 510 may detect emission of photons by the coating. In someembodiments, the transport member(s) 504 include a fluorophore that isexcited by 308 nm laser light, such ascoumarin-3-carboxy-(2,2,6,6-tetramethylpiperidine-4-yl)amide¹, and thesensor 510 detects photon emission from the excited fluorophore. In someembodiments, the coatings described above may be combined with othertypes of coatings for the transport members 504, such as a polyimidecoating. In some embodiments, the coatings described above may bepresent at locations on the transport member(s) 504 where othercoatings, such as polyamides, are absent. For example, the coatings maybe present on portions of the transport member(s) 504 within the inputcoupling 502, and the sensor 510 may be carried in the input coupling502.

In some embodiments, the laser ablation catheter 500 includes a controlpanel 518 that facilitates clinician control of the laser ablationcatheter 500. In some embodiments, the control panel 518 is formed onthe housing 503. FIG. 6 illustrates an exemplary control panel 600 thatmay be used as the control panel 518. The control panel 600 includes ahousing 602, which may be the housing 503 described above. In someembodiments, the housing 602 carries one or more clinician-operableinputs and/or one or more indicators that are operatively coupled to thecatheter controller 514. In some embodiments, the control panel 600includes a first input 604 (for example, a button) that may be actuatedby the clinician to cause the laser ablation catheter 500 to enter anautomatic mode. In the automatic mode, the catheter controller 514automatically controls actuation of the ancillary device(s) 508, forexample, in one of the manners described above (that is, the cathetercontroller 514 actuates the ancillary device(s) 508 when the sensor 510detects laser energy emitted from the transport member(s) 504). In someembodiments and when the laser ablation catheter 500 is in the automaticmode, the first input 604 may be actuated by the clinician to cause thelaser ablation catheter 500 to exit the automatic mode. In someembodiments, the control panel 600 includes a first indicator 606 thatindicates when the laser ablation catheter 500 is in the automatic mode.The first indicator 606 may be a visual indicator (for example, alight-emitting diode), an audible indicator (for example, a speaker thatemits sound), a tactile indicator (for example, an actuator thatfacilitates vibration of the control panel 600), or the like.

In some embodiments, the control panel 600 includes a second input 608(for example, a button) that may be actuated by the clinician tomanually actuate the ancillary device(s) 508. That is, the clinician maypress the second input 608 to cause the catheter controller 514 toactuate the ancillary device(s) 508 regardless of whether the sensor 510detects laser energy emitted from the transport member(s) 504.

In some embodiments, the control panel 600 includes a third input 610(for example, a button) that may be actuated by the clinician to causethe laser ablation catheter 500 to turn “on” and “off”. When the laserablation catheter 500 is “on”, the first and second inputs 604 and 608may be actuated to cause the catheter controller 514 to actuate theancillary device(s) 508 as described above. When the laser ablationcatheter 500 is “off”, the catheter controller 514 does not actuate theancillary device(s) 508 when the first or second inputs 604 and 608 areactuated. In some embodiments, the control panel 600 includes a secondindicator 612 that indicates when the laser ablation catheter 500 is“on”. The second indicator 612 may be a visual indicator (for example, alight-emitting diode), an audible indicator (for example, a speaker thatemit sounds), a tactile indicator (for example, an actuator thatfacilitates vibration of the control panel 600), or the like.

In some embodiments, the control panel 600 includes a third indicator614 that indicates when the sensor 510 detects laser energy emitted fromthe transport member(s) 504. The third indicator 614 be a visualindicator (for example, a light-emitting diode), an audible indicator(for example, a speaker that emit sounds), a tactile indicator (forexample, an actuator that facilitates vibration of the control panel600), or the like.

In some embodiments, the control panel 600 lacks the inputs andindicators described above and instead includes a touch-sensitivedisplay device (not shown; for example, a touch-sensitive LCD device).The touch-sensitive display device acts as an input device that theclinician may manipulate to cause the laser ablation catheter 500 toenter and exit the automatic mode and manually actuate the ancillarydevice(s) 508. The touch-sensitive display device also provides visualindications when the laser ablation catheter 500 is in the automaticmode and when the sensor 510 detects laser energy emitted from thetransport member(s) 504.

FIG. 7 illustrates an exemplary method for treating a subject by using alaser energy generator and a laser energy delivery device, such as thebase unit 102 and the laser ablation catheter 500, respectively. Atblock 702, the distal end 509 of the laser ablation catheter sheath 507is positioned within the appropriate tissue of the subject (for example,the vasculature). As a result, the distal ends 506 of the transportmembers 504 are positioned within the appropriate tissue of the subject.At block 704, the laser ablation catheter 500 is placed in the automaticmode, for example, by pressing the first input 604. At block 706, thebase unit 102 is activated to deliver laser energy from the base unit102, through the laser ablation catheter 500, and to the subject. Insome embodiments, for example, the base unit 102 is activated bypressing the foot-operated pedal switch 300. At block 708, the laserablation catheter 500 detects transmission of laser energy through thetransport members 504. In some embodiments, for example, the sensor 510detects laser energy emitted from the transport members 504 and sends asignal to the catheter controller 514. At block 710, the laser ablationcatheter 500 activates the ancillary device(s) 508. In some embodiments,for example, the catheter controller 514 delivers energy from the powersupply 516 to actuate the ancillary device(s) 508 upon receiving thesignal from the sensor 510. In some embodiments, blocks 706, 708, 710may occur substantially simultaneously. Blocks 706, 708, and 710 may berepeated any number of times. The distal end 509 of the laser ablationcatheter sheath 507 may be translated within the tissue of the subjectduring blocks 706, 708, and 710.

FIG. 8 illustrates an exemplary laser ablation catheter 800. The laserablation catheter 800 includes an input coupling 802 that couples to anoutput coupling of a laser energy generator, such as the output coupling112 of the base unit 102. The input coupling 802 carries proximal endsof transport members 804 (see FIG. 9) that receive laser energy from thebase unit. The transport members 804 transmit laser energy from theirproximal ends, through a housing 806 of the laser ablation catheter 800,and to their distal ends, which are disposed at a distal tip or outerband 808 of a sheath 810 of the laser ablation catheter 800. Thetransport members 804 emit laser energy from their distal ends, or fromthe distal tip 808, to ablate tissue of the subject.

Generally, the laser ablation catheter 800 includes components thatfacilitate rotating the distal tip 808 and adjacent portions of thesheath 810 in an “orbital” or “eccentric” manner. The distal tip 808 mayrotate in such a manner while delivering laser energy to tissue of asubject to ablate tissue in a circular pattern that is larger than thedistal tip 808. The components of the laser ablation catheter 800 alsofacilitate rotating the distal tip 808 in an automatic mode (that is,rotating the distal tip 808 when laser energy is transmitted through thelaser ablation catheter 800) or a manual mode (that is, rotating thedistal tip 808 regardless of whether laser energy is transmitted throughthe laser ablation catheter 800). In some embodiments, the components ofthe laser ablation catheter 800 inhibit the distal tip 808 fromconsecutively rotating more than several rotations in one direction toinhibit damaging the transport members 804. These aspects are describedin further detail below.

Referring to FIG. 9, in some embodiments, the input coupling 802 isadapted to couple to a laser energy generator, such as the CVX-300Excimer Laser System available from the Spectranetics Corporation. Atthe input coupling 802, the laser energy generator delivers laser energyto the proximal ends of the transport members 804 (for example, fiberoptic cables). The input coupling 802 may carry various numbers oftransport members 804. In some embodiments, the laser ablation catheterincludes 106 100 μm fiber optic cables that serve as the transportmembers 804.

The input coupling 802 couples to a flexible cord 812. In someembodiments, the flexible cord 812 includes a hollow flexible jacket 814(formed of, for example, a polymer or the like) through which thetransport members 804 extend. Opposite the input coupling 802, theflexible cord 812 couples to the housing 806 (see FIG. 10).

Referring now to FIGS. 10-12, the housing 806 includes a base 816 (seeFIGS. 10 and 11) and a cover 818 (see FIG. 12) that may be formed ofvarious materials (for example, a polymer or the like). The base 816 andthe cover 818 carry various components. The base 816 and the cover 818carry a trifurcate structure 820 that joins several components of thelaser ablation catheter 800.

The trifurcate structure 820 may be formed of various materials (forexample, a polymer or the like). Referring to FIGS. 11, 13, and 14, thetrifurcate structure 820 includes a first input branch 822 that definesa first passageway 824 (see FIG. 13). The first input branch 822 couplesto the jacket 814 of the flexible cord 812, and the first passageway 824receives the transport members 804 (see FIG. 14). The trifurcatestructure 820 also includes a second input branch 826 that defines asecond passageway 828 (see FIG. 13). The second passageway 828 receivesa drive or torque wire 830 (see FIG. 13; a flexible wire formed of, forexample, stainless steel). As described in further detail below, thedrive wire 830 rotates relative to the housing 806 to eccentricallyrotate the distal tip 808 of the laser ablation catheter sheath 810. Thetrifurcate structure 820 further includes a third input branch 832 thatdefines a third passageway 834 (see FIG. 13). The third input branch 832couples to a guide wire port 833, such as a Luer connector. The guidewire port 833 in turn couples to a guide wire lumen 835 (for example,via an ultraviolet-cured adhesive; see FIG. 14; the guide wire lumen 835may be a flexible lumen formed of, for example, stainless steel andadapted to receive, for example, a 0.018 diameter guide wire) that isdisposed in the third passageway 834.

In some embodiments, one or more of the input branches 822, 826, and 832are elongated structures. For example, the first and third inputbranches 822 and 832 may be elongated structures. In some embodiments,one or more of the input branches 822, 826, and 832 are relatively shortstructures. For example, the second input branch 826 may be a relativelyshort structure.

The input branches 822, 826, and 832 couple to an output branch 836, andthe input passageways 824, 828, and 834 are in communication with anoutput passageway 838 (see FIG. 13) defined by the output branch 836.The transport members 804, the drive wire 830, and the guide wire lumen835 extend from the first passageway 824, the second passageway 828, andthe third passageway 834, respectively, and into the output passageway838. As described in further detail below, the output branch 836 couplesto the laser ablation catheter sheath 810 opposite the input branches822, 826, and 832.

Referring again to FIG. 11, the base 816 and the cover 818 of thehousing 806 also carry a prime mover 840 that is coupled to androtatably drives the drive wire 830. In some embodiments, the primemover 840 includes an electric motor 842 that drives a speed reducer844, such as a gearbox. The speed reducer 844 drives a coupling 846 byconnecting to the proximal end of the coupling 846, and the coupling 846drives the drive wire 830. In some embodiments, the distal end of thecoupling 846 includes a non-circular opening (for example, a rectangularopening; not shown) that receives a non-circular proximal end of thedrive wire 830 (for example, a rectangular proximal end of the drivewire 830). The non-circular opening of the coupling 846 and thenon-circular proximal end of the drive wire 830 may be other shapes,such as triangular, trapezoidal, elliptical, or the like. As such, thedrive wire 830 may be rotatably fixed to and translatably movablerelative to the coupling 846 such that the drive wire 830 may translaterelative to the coupling 846 as the drive wire 830 eccentrically rotatesthe distal tip 808 of the laser ablation catheter sheath 810.

The prime mover 840 and the drive wire 830 together form an ancillarydevice that augments tissue ablation. Specifically, the prime mover 840and the drive wire 830 facilitate rotating the distal tip 808 andadjacent portions of the sheath in an eccentric manner.

The housing 806 further carries a catheter electronic controller 848. Insome embodiments, the catheter controller 848 is a circuit board. Thecatheter controller 848 delivers energy from a power supply 850, such asa battery, to the prime mover 840 to drive the prime mover 840, thedrive wire 830, and the distal tip 808 of the sheath 810.

In some embodiments, the catheter controller 848 includes a rotationalposition sensor 852, such as an optical encoder, that is carried by theelectric motor 842. The rotational position sensor 852 determines therotational position of the shaft (not shown) of the electric motor 842.As a result, the rotational position sensor 852 determines therotational position of the drive wire 830 and the distal tip 808 of thesheath 810. In some embodiments, the catheter controller 848 usesrotational position information to inhibit the distal tip 808 fromconsecutively rotating more than several rotations in one direction,which in turn inhibits damaging the transport members 804. For example,the catheter controller 848 may limit the rotational range of motion ofthe distal tip 808 by de-energizing the electric motor 842 when thedistal tip 808 reaches a clockwise rotational limit or acounterclockwise rotational limit. When the distal tip 808 is at theclockwise rotational limit, the catheter controller 848 may drive theelectric motor 842, and the distal tip 808, in a counterclockwiserotational direction. Similarly, when the distal tip 808 is at thecounterclockwise rotational limit, the catheter controller 848 may drivethe electric motor 842, and the distal tip 808, in a clockwiserotational direction.

Referring to FIGS. 11 and 13, the housing 806 further carries a laserenergy transmission sensor 854. The sensor 854 detects a relativelysmall amount of laser energy that is emitted, or “leaked”, from thetransport members 804 when laser energy is transmitted through thetransport members 804. In some embodiments, the sensor 854 includes aphotodiode 856 (see FIG. 13) that is disposed in an opening 858 formedin the first input branch 822 of the trifurcate structure 820. Theopening 858 is in communication with the first passageway 824 of thetrifurcate structure 820, and the photodiode 856 is disposed adjacentthe transport members 804 to detect laser energy emitted therefrom.

In some embodiments, the sensor 854 detects various wavelengths orvarious ranges of wavelengths of emitted laser energy. In someembodiments, the sensor 854 detects emitted laser energy having awavelength of 308 nm.

In some embodiments, the sensor 854 detects emitted laser energy along astraight portion of one or more of the transport members 804. In someembodiments, one or more of the transport members 804 form a curve orbend within the first passageway 824, and the sensor 854 detects laserenergy emitted from the bend. The bend may take a variety of shapes andforms. For example, the bend could be formed as one or more turns,loops, or coils in one or more transport members 804.

In some embodiments, the portion of the transport members 804 that emitslaser energy toward the sensor 854 includes a buffer, coating, sheath,sticker, or patch that facilitates indirect detection of emitted laserenergy by the sensor 854. For example, the transport members 804 mayinclude a coating that fluoresces when exposed to laser energy, and thesensor 854 may detect emission of photons by the coating. In someembodiments, the transport members 804 include a fluorophore that isexcited by 308 nm laser light, such ascoumarin-3-carboxy-(2,2,6,6-tetramethylpiperidine-4-yl)amide¹, and thesensor 854 detects photon emission from the excited fluorophore. In someembodiments, the coatings described above may be combined with othertypes of coatings for the transport members 804, such as a polyimidecoating.

When the sensor 854 detects laser energy emitted from the transportmembers 804, the sensor 854 transmits a signal to a catheter controller848. In some embodiments, upon receiving the signal from the sensor 854,the catheter controller 848 actuates the prime mover 840 to rotate thedrive wire 830 and the distal tip 808 of the sheath 810.

In some embodiments, the catheter controller 848 actuates the primemover 840 (for example, by delivering energy from the power supply 850to the prime mover 840) only when the sensor 854 detects laser energyemitted from the transport members 804. When the sensor 854 does notdetect emitted laser energy, the catheter controller 848 deactivates theprime mover 840 (for example, the catheter controller 848 stopsdelivering energy from the power supply 850 to the prime mover 840).

In some embodiments, the catheter controller 848 continuously actuatesthe prime mover 840 (for example, by delivering energy from the powersupply 850 to the prime mover 840) when the sensor 854 detects a seriesof emitted laser energy pulses from the transport members 804. When thesensor 854 does not detect emitted laser energy from the transportmembers 804 for a time period that is longer than the time periodbetween laser energy pulses, the catheter controller 848 deactivates theprime mover 840 (for example, the catheter controller 848 stopsdelivering energy from the power supply 850 to the prime mover 840).

In some embodiments, the catheter controller 848 actuates the primemover 840 for a predetermined time period after the sensor 854 detectslaser energy emitted from the transport members 804 (for example, bydelivering energy from the power supply 850 to the prime mover 840).After the predetermined time period elapses, the catheter controller 848deactivates the prime mover 840 (for example, the catheter controller848 stops delivering energy from the power supply 850 to the prime mover840).

In some embodiments, the laser ablation catheter 800 includes a controlpanel 860 (see FIG. 15) that facilitates clinician control of the laserablation catheter 800. In some embodiments, the control panel 860 isformed on the housing 806. The control panel 860 includes severalclinician-operable inputs and/or indicators that are operatively coupledto the catheter controller 848. The control panel 860 includes a firstinput 862 (for example, a button). The first input 862 may be actuatedby the clinician to cause the laser ablation catheter 800 to enter anautomatic mode. In the automatic mode, the catheter controller 848automatically controls actuation of the prime mover 840 and, as aresult, rotation of the drive wire 830 and the distal tip 808 of thesheath 810. Specifically, the catheter controller 848 actuates the primemover 840 only when the sensor 854 detects laser energy is being emittedfrom the transport members 804. In some embodiments and when the laserablation catheter 800 is in the automatic mode, the first input 862 maybe actuated by the clinician to cause the laser ablation catheter 800 toexit the automatic mode. The control panel 860 includes a first visualindicator 864 (for example, a light-emitting diode) that indicates whenthe laser ablation catheter 800 is in the automatic mode.

The control panel 860 includes a second input 866 (for example, abutton) that may be actuated by the clinician to manually actuate theprime mover 840. That is, the clinician may press the second input 866to cause the catheter controller 848 to actuate the prime mover 840regardless of whether the sensor 854 detects laser energy emitted fromthe transport members 804. In addition, pressing the second input 866actuates the prime mover 840 in a manner that rotates the drive wire 830and the distal tip 808 of the sheath 810 in a first direction (forexample, clockwise when facing the distal tip 808).

The control panel 860 includes a third input 868 (for example, a button)that may be actuated by the clinician to manually actuate the primemover 840. That is, the clinician may press the third input 868 to causethe catheter controller 848 to actuate the prime mover 840 regardless ofwhether the sensor 854 detects laser energy emitted from the transportmembers 804. In addition, pressing the third input 868 actuates theprime mover 840 in a manner that rotates the drive wire 830 and thedistal tip 808 of the sheath 810 in a second direction (for example,counterclockwise when facing the distal tip 808).

In some embodiments, the first input 862 may be actuated by theclinician to cause the laser ablation catheter 800 to enter a “watching”mode. In the watching mode, the catheter controller 848 actuates theprime mover 840 when (1) the sensor 854 detects laser energy is beingemitted from the transport members 804 and (2) one of the second input866 and the third input 868 is actuated (to cause rotation of the distaltip 808 of the sheath 810 in the first and second directions,respectively). In some embodiments and when the laser ablation catheter800 is in the watching mode, the first input 862 may be actuated by theclinician to cause the laser ablation catheter 800 to exit the watchingmode. The first visual indicator 864 may indicate when the laserablation catheter 800 is in the watching mode.

The control panel 860 includes a fourth input 870 (for example, abutton). The fourth input 870 may be actuated by the clinician toactuate the prime mover 840 in a manner that returns the drive wire 830and the distal tip 808 of the sheath 810 to a rotational “home”position. In some embodiments, the rotational home position isapproximately half way between the clockwise rotational limit and thecounterclockwise rotational limit. In some embodiments, the cathetercontroller 848 uses information received from the rotational positionsensor 852 to determine a current rotational position of the drive wire830 and the distal tip 808 of the sheath 810. The catheter controller848 compares the current rotational position to the rotational homeposition to determine the direction and amount of rotation needed toreturn of the drive wire 830 and the distal tip 808 of the sheath 810 tothe rotational home position.

In some embodiments, the laser ablation catheter 800 includes amechanical device (for example, one or more springs) that is adapted tourge the drive wire 830 and the distal tip 808 of the sheath 810 to therotational home position.

In some embodiments, the control panel 860 includes a fifth input 872(for example, a button) that may be actuated by the clinician to causethe laser ablation catheter 800 to turn “on” and “off”. When the laserablation catheter 800 is “on”, the inputs 862, 866, 868, and 870 may beactuated to cause the catheter controller 848 to actuate the prime mover840 as described above. When the laser ablation catheter 800 is “off”,the catheter controller 848 does not actuate the prime mover 840 whenthe inputs 862, 866, 868, and 870 are actuated. In some embodiments, thecontrol panel 860 includes a second visual indicator 874 (for example, alight-emitting diode) that indicates when the laser ablation catheter800 is “on”.

In some embodiments, the control panel 860 includes a third visualindicator 876 (for example, a light-emitting diode) that indicates thepresence of a device error or fault condition (for example, as detectedby the catheter controller 848). For example, device errors and faultconditions may include the prime mover 840 rotating past a rotationallimit, a reduction in power to the prime mover 840, and the prime mover840 failing to rotate in response to actuation of one or more of theinputs 866, 868, and 870.

In some embodiments, when the laser ablation catheter 800 is in theautomatic mode and the catheter controller 848 automatically controlsactuation of the prime mover 840, the catheter controller 848 monitorsthe rotational position of the drive wire 830 and the distal tip 808 ofthe sheath 810 (for example, based on information received from therotational position sensor 852). When the drive wire 830 and the distaltip 808 of the sheath 810 reach one of the rotational limits, thecatheter controller 848 may automatically reverse the direction ofrotation of the prime mover 840, the drive wire 830 and the distal tip808 of the sheath 810. That is, the prime mover 840 may rotate the drivewire 830 and the distal tip 808 of the sheath 810 in a clockwisedirection until the drive wire 830 and the distal tip 808 reach theclockwise rotational limit. Thereafter, the prime mover 840 may rotatethe drive wire 830 and the distal tip 808 in a counterclockwisedirection. Similarly, the prime mover 840 may rotate the drive wire 830and the distal tip 808 in the counterclockwise direction until the drivewire 830 and the distal tip 808 reach the counterclockwise rotationallimit. Thereafter, the prime mover 840 may rotate the drive wire 830 andthe distal tip 808 in the clockwise direction. In some embodiments, whenthe laser ablation catheter 800 is in the automatic mode and the laserenergy transmission sensor 854 detects laser energy emitted from thetransport members 804, the catheter controller 848 actuates the primemover 840 in a manner that rotates the distal tip 808 of the sheath 810in a first direction (for example, a clockwise direction) for severalrotations (for example, six rotations), then rotates the distal tip 808in a second direction (for example, a counterclockwise direction) forseveral rotations (for example, twelve rotations), then rotates thedistal tip 808 in the first direction for several rotations (forexample, twelve rotations), and so forth. The distal tip 808 maycontinue to rotate in this manner until the laser energy transmissionsensor 854 no longer detects laser energy emitted from the transportmembers 804 or for a predetermined number of cycles.

In some embodiments, when the distal tip 808 of the sheath 810 ismanually rotated by pressing the inputs 866 and 868, the cathetercontroller 848 monitors the rotational position of the drive wire 830and the distal tip 808 (for example, based on information received fromthe rotational position sensor 852). When the drive wire 830 and thedistal tip 808 reach one of the rotational limits, the cathetercontroller 848 may automatically inhibit rotation of the drive wire 830and the distal tip 808 (for example, by de-energizing the prime mover840). That is, the clinician may actuate the second input 866 to rotatethe drive wire 830 and the distal tip 808 in a first direction (forexample, a clockwise direction) until the drive wire 830 and the distaltip 808 reach a first of the rotational limits (for example, theclockwise rotational limit). The catheter controller 848 thenautomatically inhibits rotation of the drive wire 830 and the distal tip808 in the first direction regardless of whether the clinician actuatesthe second input 866. However, the clinician may actuate the third input868 to rotate the drive wire 830 and the distal tip 808 in a seconddirection (for example, a counterclockwise direction). Similarly, theclinician may actuate the third input 868 to rotate the drive wire 830and the distal tip 808 in the second direction (for example, thecounterclockwise direction) until the drive wire 830 and the distal tip808 reach a second of the rotational limits (for example, thecounterclockwise rotational limit). The catheter controller 848 thenautomatically inhibits rotation of the drive wire 830 and the distal tip808 in the second direction regardless of whether the clinician actuatesthe third input 868. However, the clinician may actuate the second input866 to rotate the drive wire 830 and the distal tip 808 in the firstdirection (for example, the clockwise direction).

Referring now to FIGS. 16 and 17A-17C, the laser catheter sheath 810 isadapted to be positioned within the vasculature of the subject. Thelaser catheter sheath 810 includes an outer jacket 878 that is coupledto the output branch 836 of the trifurcate structure 820 (see FIG. 11).The outer jacket 878 is a flexible component that may be formed of, forexample, a polymer. The outer jacket 878 defines a sheath passageway 880that is in communication with the output passageway 838 of thetrifurcate structure 820. The sheath passageway 880 receives thetransport members 804, the drive wire 830, and the guide wire lumen 835from the output passageway 880, and the transport members 804, the drivewire 830, and the guide wire lumen 835 extend through the sheathpassageway 880 from a proximal end of the sheath 810 to the distal tip808.

FIG. 17A illustrates a cross-section of a proximal portion of the laserablation catheter sheath 810. At the proximal portion of the laserablation catheter sheath 810, the transport members 804, the drive wire830, and the guide wire lumen 835 are translatably and rotatablydisposed within the outer jacket 878. That is, at the proximal portionof the laser ablation catheter sheath 810, the transport members 804,the drive wire 830, the guide wire lumen 835, and the outer jacket 878are movable relative to each other. In some embodiments, at the proximalportion of the laser ablation catheter sheath 810, the drive wire 830may have a non-circular cross-sectional shape. For example, the proximalportion of the drive wire 830 may have a rectangular cross-sectionalshape including a width of about 0.020 inches and a height of about0.008 inches. The non-circular cross-sectional shape of the drive wire830 may extend proximally into the housing 806 and, as described brieflyabove, couple to a non-circular opening of the prime mover coupling 846.The proximal portion of the drive wire 830 may also have othernon-circular cross-sectional shapes, such as triangular, square,pentagonal, hexagonal, octagonal, etc. Additionally or alternatively,the central portion and distal portion of the drive wire 830 may alsohave such non-circular cross-sectional shapes. For example, the proximalportion of the drive wire 830 may have a circular cross-sectional shape,and the distal portion of the drive wire 830 may have a non-circularcross-sectional shape.

FIG. 17B illustrates a cross-section of an intermediate portion of thelaser ablation catheter sheath 810. At the intermediate portion of thelaser ablation catheter sheath 810, the transport members 804, the drivewire 830, and the guide wire lumen 835 are translatably and rotatablydisposed within the outer jacket 878. That is, at the intermediateportion of the laser ablation catheter sheath 810, the transport members804, the drive wire 830, the guide wire lumen 835, and the outer jacket878 are movable relative to each other. In some embodiments, at theintermediate portion of the laser ablation catheter sheath 810, thedrive wire 830 may have a circular cross-sectional shape (with adiameter of, for example, 0.014 inches).

FIGS. 17C and 17D illustrate an end view and a side view, respectively,of the distal tip 808 of the laser ablation catheter sheath 810. In someembodiments, at the distal tip 808, the drive wire 830 may have acircular cross-sectional shape (with a diameter of, for example, 0.021inches). In some embodiments, the drive wire 830 may have a circularcross-sectional shape that tapers to a smaller diameter proceedingtoward the distal tip 808. Such a structure may facilitatedeliverability through anatomy. At the distal tip 808, the guide wirelumen 835 is coupled to the drive wire 830 and the distal tip 808 by afirst connection 882 (for example, a welded connection). In addition,the first connection 882, the drive wire 830, and the transport members804 are coupled to each other by a second connection 884 (for example,an epoxy connection). In some embodiments and as shown in FIG. 17D, thetransport members 804, the guide wire lumen 835, the drive wire 830, thefirst connection 882, and the second connection 884 form an atraumatic,conical-shaped leading edge of the distal tip 808. The leading edge mayform an angle of about 23 degrees with a plane perpendicular to alongitudinal axis of the laser ablation catheter sheath 810. At thedistal tip 808, the guide wire lumen 835 and the drive wire 830 areeccentrically positioned within the distal tip 808. Due to thisarrangement, the distal tip 808 rotates in an “orbital” or “eccentric”manner about an eccentric axis when the drive wire 830 rotates. Theposition of the eccentric axis depends on the stiffness of the drivewire 830 and the stiffness of the guide wire, among other things. In anycase, the eccentric rotation of the distal tip 808 permits the transportmembers 804, which are positioned in a semi-circular array within thedistal tip 808, to deliver laser energy and ablate tissue in a circularpattern that is larger than the distal tip 808.

Again, as the prime mover 840 rotates, the drive wire 830 rotates, whichin turn causes the distal tip 808 of the sheath 810 to rotate. That is,every rotation of the prime mover 840 creates a corresponding rotationof the drive wire 830. Outside the subject's vasculature and when thesheath 810 is straight, there a one-to-one ratio of rates of rotationbetween the prime mover 840, the drive wire 830, and the distal tip 808of the sheath 810. However, when the sheath 810 is placed within asubject's vasculature, which typically includes bends, there is lessthan a one-to-one ratio of rates of rotation between the (1) prime mover840 and the proximal end of the drive wire 830 and (2) the distal end ofthe drive wire 830 and the distal tip 808 of the sheath 810.

In some embodiments, the outer jacket 878, the transport members 804,and the guide wire lumen 835 rotate to a limited extent at the proximaland intermediate portions of the sheath 810 as the drive wire 830rotates. These components rotate in this manner because they are coupledto the distal tip 808 of the sheath 810.

FIGS. 18A-18E illustrate an exemplary process diagram and method fortreating a subject by using a laser energy generator and a laser energydelivery device, such as the base unit 102 and the laser ablationcatheter 800, respectively. At block 1802, the distal tip 808 of thelaser ablation catheter sheath 810 is positioned within the appropriatetissue of the subject (for example, the vasculature). As a result, thedistal ends of the transport members 504 are positioned within theappropriate tissue of the subject. In some embodiments, the cathetersheath 810 is positioned within the appropriate tissue of the subject byinserting the distal end of a guide wire (not shown) into the guide wireport 833. The distal end of the guide wire is translated through thetrifurcate structure 820 and the laser ablation catheter sheath 810 suchthat this distal end of the guide wire protrudes from the distal tip 808of the laser ablation catheter sheath 810. The guide wire is translatedthrough the vasculature of the subject and crosses a blockage to beablated. The laser ablation catheter sheath 810 is then translated alongthe guide wire to position the distal tip 808 near the blockage.

After the distal tip 808 of the laser ablation catheter sheath 810 ispositioned within the appropriate tissue of the subject, laser energymay be selectively delivered to the subject (for example, by pressingthe foot-operated pedal switch 300).

At block 1804, the catheter controller 848 determines if any of theinputs 862, 866, 868, or 870 have been actuated by the clinician.

If the first input 862 has been actuated, the laser ablation catheter800 enters the automatic mode (see FIG. 18B). In the automatic mode, atblock 1806, the catheter controller 848 determines if laser energy isbeing transmitted through the transport members 804 (for example, byreceiving the signal from the laser emission energy sensor 854). Iflaser energy is not being transmitted through the transport members 804,the catheter controller 848 continues to monitor the transport members804 for laser energy transmission (that is, the catheter controller 848does not actuate the prime mover 840 to rotate the drive wire 830 andthe distal tip 808). If laser energy is being transmitted through thetransport members 804, the catheter controller 848 determines if thedrive wire 830 and the distal tip 808 are at the first rotational limit(see block 1808; for example, based on information received from therotational position sensor 852). If the drive wire 830 and the distaltip 808 are not at the first rotational limit, the catheter controller848 actuates the prime mover 840 to rotate the drive wire 830 and thedistal tip 808 in a first direction (see block 1810; for example, aclockwise direction). The catheter controller 848 continues to actuatethe prime mover 840 until (1) the drive wire 830 and the distal tip 808reach the first rotational limit (for example, a clockwise rotationallimit), or (2) laser energy is no longer transmitted through thetransport members 804 (see block 1806). When the drive wire 830 and thedistal tip 808 are at the first rotational limit, the cathetercontroller 848 does not actuate the prime mover 840 to rotate the drivewire 830 and the distal tip 808 in the first direction, and the processcontinues to block 1812.

At block 1812, the catheter controller 848 determines if laser energy isbeing transmitted through the transport members 804 (for example, byreceiving the signal from the laser emission energy sensor 854). Iflaser energy is not being transmitted through the transport members 804,the catheter controller 848 continues to monitor the transport members804 for laser energy transmission (that is, the catheter controller 848does not actuate the prime mover 840 to rotate the drive wire 830 andthe distal tip 808). If laser energy is being transmitted through thetransport members 804, the catheter controller 848 determines if thedrive wire 830 and the distal tip 808 are at the second rotational limit(see block 1814; for example, based on information received from therotational position sensor 852). If the drive wire 830 and the distaltip 808 are not at the second rotational limit, the catheter controller848 actuates the prime mover 840 to rotate the drive wire 830 and thedistal tip 808 in a second direction (see block 1816; for example, acounterclockwise direction). The catheter controller 848 continues toactuate the prime mover 840 until (1) the drive wire 830 and the distaltip 808 reach the second rotational limit (for example, acounterclockwise rotational limit), or (2) laser energy is no longertransmitted through the transport members 804 (see block 1812). When thedrive wire 830 and the distal tip 808 are at the second rotationallimit, the catheter controller 848 does not actuate the prime mover 840to rotate the drive wire 830 and the distal tip 808 in the seconddirection, and the process returns to block 1806.

The process illustrated in FIG. 18B may continue indefinitely, or thefirst input 862 may be actuated at any point during the process to exitthe automatic mode and return the process to block 1804 (see FIG. 18A).

Briefly returning to FIG. 18A, if the second input 866 has beenactuated, the laser ablation catheter 800 enters a manual drive mode(see FIG. 18C). At block 1818, the catheter controller 848 determines ifthe drive wire 830 and the distal tip 808 are at the first rotationallimit (for example, based on information received from the rotationalposition sensor 852). If the drive wire 830 and the distal tip 808 areat the first rotational limit, the process returns to block 1804 (seeFIG. 18A; that is, the catheter controller 848 does not actuate theprime mover 840 to rotate the drive wire 830 and the distal tip 808). Ifthe drive wire 830 and the distal tip 808 are not at the firstrotational limit, the catheter controller 848 actuates the prime mover840 to rotate the drive wire 830 and the distal tip 808 in the firstdirection (see block 1820). The process then returns to block 1804 (seeFIG. 18A), although the second input 866 may be continuously actuated(for example, continuously pressed) to continuously rotate the drivewire 830 and the distal tip 808 in the first direction (until reachingthe first rotational limit).

Briefly returning to FIG. 18A, if the third input 868 has been actuated,the laser ablation catheter 800 enters a manual drive mode (see FIG.18D). At block 1822, the catheter controller 848 determines if the drivewire 830 and the distal tip 808 are at the second rotational limit (forexample, based on information received from the rotational positionsensor 852). If the drive wire 830 and the distal tip 808 are at thesecond rotational limit, the process returns to block 1804 (see FIG.18A; that is, the catheter controller 848 does not actuate the primemover 840 to rotate the drive wire 830 and the distal tip 808). If thedrive wire 830 and the distal tip 808 are not at the second rotationallimit, the catheter controller 848 actuates the prime mover 840 torotate the drive wire 830 and the distal tip 808 in the second direction(see block 1824). The process then returns to block 1804 (see FIG. 18A),although the third input 868 may be continuously actuated (for example,continuously pressed) to continuously rotate the drive wire 830 and thedistal tip 808 in the second direction (until reaching the secondrotational limit).

Briefly returning to FIG. 18A, if the fourth input 870 has beenactuated, the drive wire 830 and the distal tip 808 return to therotational home position (see FIG. 18E). At block 1826, the cathetercontroller 848 determines if the drive wire 830 and the distal tip 808are at the rotational home position (for example, based on informationreceived from the rotational position sensor 852). If the drive wire 830and the distal tip 808 are at the rotational home position, the processreturns to block 1804 (see FIG. 18A; that is, the catheter controller848 does not actuate the prime mover 840 to rotate the drive wire 830and the distal tip 808). If the drive wire 830 and the distal tip 808are not at the rotational home position, the catheter controller 848actuates the prime mover 840 to rotate the drive wire 830 and the distaltip 808 toward the rotational home position (see block 1828). The drivewire 830 and the distal tip 808 rotate until they reach the rotationalhome position, and the process then returns to block 1804 (see FIG.18A).

In some embodiments, any of the catheter controllers described herein(for example, the catheter controller 514 or 848) may include anon-transitory tangible computer-readable storage medium (for example,flash memory or the like) and a processor. The non-transitory tangiblecomputer-readable storage medium has stored thereon instructions which,when executed by the processor, cause the processor to perform any ofthe methods or processes described herein (for example, the methodillustrated in FIGS. 18A-18E).

FIG. 19 illustrates an exemplary control panel 1900 of a laser ablationcatheter, such as the laser ablation catheter 800 described above. Thatis, the laser ablation catheter 800 may include the control panel 1900in lieu of the control panel 860 described above. Components of thelaser ablation catheter 800 are referenced in the following descriptionfor illustrative purposes, although it is to be understood that thecontrol panel 1900 may be used with other laser ablation catheters.

The control panel 1900 facilitates clinician control of the laserablation catheter. The control panel 1900 includes severalclinician-operable inputs and/or indicators that are operatively coupledto the catheter controller 848.

The control panel 1900 includes a first input 1902 (for example, abutton) that may be actuated by the clinician to actuate the prime mover840. That is, the clinician may press the first input 1902 to cause thecatheter controller 848 to actuate the prime mover 840 and therebyrotate the drive wire 830 and the distal tip 808 of the sheath 810. Inaddition, pressing the first input 1902 actuates the prime mover 840 ina manner that rotates the drive wire 830 and the distal tip 808 of thesheath 810 in a first direction (for example, clockwise when facing thedistal tip 808). The control panel 1900 includes a first visualindicator 1904 (for example, a light-emitting diode) that indicates whenthe first input 1902 is actuated and the prime mover 840, the drive wire830, and the distal tip 808 of the sheath 810 are rotating in the firstdirection.

The control panel 1900 includes a second input 1906 (for example, abutton) that may be actuated by the clinician to actuate the prime mover840. That is, the clinician may press the second input 1906 to cause thecatheter controller 848 to actuate the prime mover 840 and therebyrotate the drive wire 830 and the distal tip 808 of the sheath 810. Inaddition, pressing the second input 1906 actuates the prime mover 840 ina manner that rotates the drive wire 830 and the distal tip 808 of thesheath 810 in a second direction (for example, counterclockwise whenfacing the distal tip 808). The control panel 1900 includes a secondvisual indicator 1908 (for example, a light-emitting diode) thatindicates when the second input 1906 is actuated and the prime mover840, the drive wire 830, and the distal tip 808 of the sheath 810 arerotating in the second direction.

The control panel 1900 further includes a plurality of visualindicators, such as a third visual indicator 1910A (for example, alight-emitting diode), a fourth visual indicator 1910B (for example, alight-emitting diode), a fifth visual indicator 1910C (for example, alight-emitting diode), a sixth visual indicator 1910D (for example, alight-emitting diode), and a seventh visual indicator 1910E (forexample, a light-emitting diode). The visual indicators may be energized(for example, illuminated) based on the rotational position of the primemover 840 (as determined by the rotational position sensor 852), theproximal end of the drive wire 830, and, generally, the distal end ofthe drive wire 830 and the distal tip 808 of the sheath 810.

For example, one or more of the visual indicators may be energized whenthe rotational position of the prime mover 840 reaches or passes aspecific threshold, and one of the visual indicators may be energizedwhen the rotational position of the prime mover 840 has not reached athreshold. As a specific example, the prime mover 840 may have a “home”position in which the drive wire 830 and the distal end of the sheath810 are not rotated relative to the housing 806. From the home position,the prime mover 840 may rotate over an angle α (for example, 2160degrees) in a first direction (that is, the prime mover 840 may rotateuntil it reaches a first rotational limit, referred to here as +α). Thefirst direction may be, for example, clockwise when facing the distaltip 808. Similarly, from the home position the prime mover 840 mayrotate over the angle α in a second direction (that is, the prime mover840 may rotate until it reaches a second rotational limit, referred tohere as −α). The second direction may be, for example, counterclockwisewhen facing the distal tip 808. As such, the rotational range of theprime mover 840 is 2α (for example, 4320 degrees). The rotationalposition of the prime mover 840 is referred to here as β and the homeposition is defined as β=0. As such, β is positive when the rotationalposition of the prime mover 840 is closer to the first rotational limitthan the second rotational limit and β is negative when the rotationalposition of the prime mover 840 is closer to the second rotational limitthan the first rotational limit. With this definition, the visualindicator thresholds may be +α, +0.5α, −0.5α, −α, and the visualindicators may be energized, as follows:

third visual indicator 1910A: β=+α

fourth visual indicator 1910B: +α>β≥+0.5α

fifth visual indicator 1910C: +0.5α>β>−0.5α

sixth visual indicator 1910D: −0.5α≥β>−α

seventh visual indicator 1910E: β=−α

Stated another way, for example, the third visual indicator 1910A isenergized when the rotational position of the prime mover 840 is 2160degrees (that is, β=2160 degrees) and the seventh visual indicator 1910Eis energized when the rotational position of the prime mover 840 is−2160 degrees (that is, β=−2160 degrees).

As another example, each visual indicator may correspond to a portion ofthe rotational range of the prime mover 840, and each visual indicatormay be energized when the prime mover 840 is rotationally positionedwith its specific portion of the rotational range. As a specificexample, the prime mover 840 may have a “home” position in which thedrive wire 830 and the distal end of the sheath 810 are not rotatedrelative to the housing 806. From the home position, the prime mover 840may rotate over an angle α (for example, 2160 degrees) in a firstdirection (that is, the prime mover 840 may rotate until it reaches afirst rotational limit, referred to here as +α). The first direction maybe, for example, clockwise when facing the distal tip 808. Similarly,from the home position the prime mover 840 may rotate over the angle αin a second direction (that is, the prime mover 840 may rotate until itreaches a second rotational limit, referred to here as −α). The seconddirection may be, for example, counterclockwise when facing the distaltip 808. As such, the rotational range of the prime mover 840 is 2α (forexample, 4320 degrees). The rotational position of the prime mover 840is referred to here as β and the home position is defined as β=0. Assuch, β is positive when the rotational position of the prime mover 840is closer to the first rotational limit than the second rotational limitand β is negative when the rotational position of the prime mover 840 iscloser to the second rotational limit than the first rotational limit.With this definition, the visual indicators may be energized when therotational position of the prime mover 840 is as follows:

third visual indicator 1910A: +α≥β>+0.75α

fourth visual indicator 1910B: +0.75α≥β>+0.25α

fifth visual indicator 1910C: +0.25α≥β≥−0.25α

sixth visual indicator 1910D: −0.25α>β≥−0.75α

seventh visual indicator 1910E: −0.75α>β≥−α

With the previous definition and as another example, the visualindicators may be energized when the rotational position of the primemover 840 is as follows:

third visual indicator 1910A: +α≥β≥+(5/6)α

fourth visual indicator 1910B: +(5/6)α>β>+(1/6)α

fifth visual indicator 1910C: +(1/6)α≥β≥−(1/6)α

sixth visual indicator 1910D: −(1/6)α>β>−(5/6)α

seventh visual indicator 1910E: −(5/6)α≥β≥−α

With the previous definition and as yet another example, the visualindicators may be energized when the rotational position of the primemover 840 is as follows:

third visual indicator 1910A: +α≥β≥+(5/6)α

fourth visual indicator 1910B: +(5/6)α>β>+(1/3)α

fifth visual indicator 1910C: +(1/3)α≥β≥−(1/3)α

sixth visual indicator 1910D: −(1/3)α>β>−(5/6)α

seventh visual indicator 1910E: −(5/6)α≥β≥−α

The control panel 1900 further includes a third input 1912 (for example,a button) that may be actuated by the clinician to cause the laserablation catheter 800 to turn “on” and “off”. When the laser ablationcatheter 800 is “on”, the inputs 1902 and 1906 may be actuated to causethe catheter controller 848 to actuate the prime mover 840 as describedabove. When the laser ablation catheter 800 is “off”, the cathetercontroller 848 does not actuate the prime mover 840 when the inputs 1902and 1906 are actuated. In some embodiments, the control panel 1900includes an eighth visual indicator 1914 (for example, a light-emittingdiode) that indicates when the laser ablation catheter 800 is “on”.

In some embodiments, the control panel 1900 includes a ninth visualindicator 1916 (for example, a light-emitting diode) that indicates thepresence of a device error or fault condition (for example, as detectedby the catheter controller 848). For example, device errors and faultconditions may include the prime mover 840 rotating past a rotationallimit, a reduction in power to the prime mover 840, and the prime mover840 failing to rotate in response to actuation of one or more of theinputs 1902 and 1906.

FIG. 20 illustrates an exemplary control panel 2000 of a laser ablationcatheter, such as the laser ablation catheter 800 described above. Thatis, the laser ablation catheter 800 may include the control panel 2000in lieu of the control panel 860 described above. Components of thelaser ablation catheter 800 are referenced in the following descriptionfor illustrative purposes, although it is to be understood that thecontrol panel 2000 may be used with other laser ablation catheters.

The control panel 2000 facilitates clinician control of the laserablation catheter. The control panel 2000 includes severalclinician-operable inputs and/or indicators that are operatively coupledto the catheter controller 848.

The control panel 2000 includes a first input 2002 (for example, abutton) that may be actuated by the clinician to actuate the prime mover840. That is, the clinician may press the first input 2002 to cause thecatheter controller 848 to actuate the prime mover 840 and therebyrotate the drive wire 830 and the distal tip 808 of the sheath 810. Inaddition, pressing the first input 2002 actuates the prime mover 840 ina manner that rotates the drive wire 830 and the distal tip 808 of thesheath 810 in a first direction (for example, clockwise when facing thedistal tip 808). The control panel 2000 includes a first visualindicator 2004 (for example, a light-emitting diode) that indicates whenthe first input 2002 is actuated and the prime mover 840, the drive wire830, and the distal tip 808 of the sheath 810 are rotating in the firstdirection.

The control panel 2000 includes a second input 2006 (for example, abutton) that may be actuated by the clinician to actuate the prime mover840. That is, the clinician may press the second input 2006 to cause thecatheter controller 848 to actuate the prime mover 840 and therebyrotate the drive wire 830 and the distal tip 808 of the sheath 810. Inaddition, pressing the second input 2006 actuates the prime mover 840 ina manner that rotates the drive wire 830 and the distal tip 808 of thesheath 810 in a second direction (for example, counterclockwise whenfacing the distal tip 808). The control panel 2000 includes a secondvisual indicator 2008 (for example, a light-emitting diode) thatindicates when the second input 2006 is actuated and the prime mover840, the drive wire 830, and the distal tip 808 of the sheath 810 arerotating in the second direction.

The control panel 2000 further includes a plurality of visualindicators, such as a third visual indicator 2010A (for example, alight-emitting diode), a fourth visual indicator 2010B (for example, alight-emitting diode), a fifth visual indicator 2010C (for example, alight-emitting diode), a sixth visual indicator 2010D (for example, alight-emitting diode), and a seventh visual indicator 2010E (forexample, a light-emitting diode). The visual indicators may be energized(for example, illuminated) based on the rotational position of the primemover 840 (as determined by the rotational position sensor 852), theproximal end of the drive wire 830, and, generally, the distal end ofthe drive wire 830 and the distal tip 808 of the sheath 810.

For example, one or more of the visual indicators may be energized whenthe rotational position of the prime mover 840 reaches or passes aspecific threshold, and one of the visual indicators may be energizedwhen the rotational position of the prime mover 840 has not reached athreshold. As a specific example, the prime mover 840 may have a “home”position in which the drive wire 830 and the distal end of the sheath810 are not rotated relative to the housing 806. From the home position,the prime mover 840 may rotate over an angle α (for example, 2160degrees) in a first direction (that is, the prime mover 840 may rotateuntil it reaches a first rotational limit, referred to here as +α). Thefirst direction may be, for example, clockwise when facing the distaltip 808. Similarly, from the home position the prime mover 840 mayrotate over the angle α in a second direction (that is, the prime mover840 may rotate until it reaches a second rotational limit, referred tohere as −α). The second direction may be, for example, counterclockwisewhen facing the distal tip 808. As such, the rotational range of theprime mover 840 is 2α (for example, 4320 degrees). The rotationalposition of the prime mover 840 is referred to here as β and the homeposition is defined as β=0. As such, β is positive when the rotationalposition of the prime mover 840 is closer to the first rotational limitthan the second rotational limit and β is negative when the rotationalposition of the prime mover 840 is closer to the second rotational limitthan the first rotational limit. With this definition, the visualindicator thresholds may be +α, +0.5α, −0.5α, −α, and the visualindicators may be energized, as follows:

third visual indicator 2010A: β=+α

fourth visual indicator 2010B: +α>β≥+0.5α

fifth visual indicator 2010C: +0.5α>β>−0.5α

sixth visual indicator 2010D: −0.5α≥β>−α

seventh visual indicator 2010E: β=−α

Stated another way, for example, the third visual indicator 2010A isenergized when the rotational position of the prime mover 840 is 2160degrees (that is, β=2160 degrees) and the seventh visual indicator 2010Eis energized when the rotational position of the prime mover 840 is−2160 degrees (that is, β=−2160 degrees).

As another example, each visual indicator may correspond to a portion ofthe rotational range of the prime mover 840, and each visual indicatormay be energized when the prime mover 840 is rotationally positionedwith its specific portion of the rotational range. As a specificexample, the prime mover 840 may have a “home” position in which thedrive wire 830 and the distal end of the sheath 810 are not rotatedrelative to the housing 806. From the home position, the prime mover 840may rotate over an angle α (for example, 2160 degrees) in a firstdirection (that is, the prime mover 840 may rotate until it reaches afirst rotational limit, referred to here as +α). The first direction maybe, for example, clockwise when facing the distal tip 808. Similarly,from the home position the prime mover 840 may rotate over the angle αin a second direction (that is, the prime mover 840 may rotate until itreaches a second rotational limit, referred to here as −α). The seconddirection may be, for example, counterclockwise when facing the distaltip 808. As such, the rotational range of the prime mover 840 is 2α (forexample, 4320 degrees). The rotational position of the prime mover 840is referred to here as β and the home position is defined as β=0. Assuch, β is positive when the rotational position of the prime mover 840is closer to the first rotational limit than the second rotational limitand β is negative when the rotational position of the prime mover 840 iscloser to the second rotational limit than the first rotational limit.With this definition, the visual indicators may be energized when therotational position of the prime mover 840 is as follows:

third visual indicator 2010A: +α≥β>+0.75α

fourth visual indicator 2010B: +0.75α≥β>+0.25α

fifth visual indicator 2010C: +0.25α≥β≥−0.25α

sixth visual indicator 2010D: −0.25α>β≥−0.75α

seventh visual indicator 2010E: −0.75α>β≥−α

With the previous definition and as another example, the visualindicators may be energized when the rotational position of the primemover 840 is as follows:

third visual indicator 1910A: +α≥β≥+(5/6)α

fourth visual indicator 1910B: +(5/6)α>β>+(1/6)α

fifth visual indicator 1910C: +(1/6)α≥β≥−(1/6)α

sixth visual indicator 1910D: −(1/6)α>β>−(5/6)α

seventh visual indicator 1910E: −(5/6)α≥β≥−α

With the previous definition and as yet another example, the visualindicators may be energized when the rotational position of the primemover 840 is as follows:

third visual indicator 1910A: +α≥β≥+(5/6)α

fourth visual indicator 1910B: +(5/6)α>β>+(1/3)α

fifth visual indicator 1910C: +(1/3)α≥β≥−(1/3)α

sixth visual indicator 1910D: −(1/3)α>β>−(5/6)α

seventh visual indicator 1910E: −(5/6)α≥β≥−α

The control panel 2000 further includes a third input 2012 (for example,a button) that may be actuated by the clinician to cause the laserablation catheter 800 to turn “on” and “off”. When the laser ablationcatheter 800 is “on”, the inputs 2002 and 2006 may be actuated to causethe catheter controller 848 to actuate the prime mover 840 as describedabove. When the laser ablation catheter 800 is “off”, the cathetercontroller 848 does not actuate the prime mover 840 when the inputs 2002and 2006 are actuated. In some embodiments, the control panel 2000includes an eighth visual indicator 2014 (for example, a light-emittingdiode) that indicates when the laser ablation catheter 800 is “on”.

The control panel 2000 includes a fourth input 2016 (for example, abutton). The fourth input 2016 may be actuated by the clinician to causethe laser ablation catheter 800 to enter an automatic mode. In theautomatic mode, the catheter controller 848 automatically controlsactuation of the prime mover 840 and, as a result, rotation of the drivewire 830 and the distal tip 808 of the sheath 810. Specifically, thecatheter controller 848 actuates the prime mover 840 only when thesensor 854 detects laser energy is being emitted from the transportmembers 804. In some embodiments and when the laser ablation catheter800 is in the automatic mode, the fourth input 2016 may be actuated bythe clinician to cause the laser ablation catheter 800 to exit theautomatic mode. The control panel 2000 includes a ninth visual indicator2018 (for example, a light-emitting diode) that indicates when the laserablation catheter 800 is in the automatic mode.

In some embodiments, the fourth input 2016 may be actuated by theclinician to cause the laser ablation catheter 800 to enter a “watching”mode. In the watching mode, the catheter controller 848 actuates theprime mover 840 when (1) the sensor 854 detects laser energy is beingemitted from the transport members 804 and (2) one of the first input2002 and the second input 2006 is actuated (to cause rotation of thedistal tip 808 of the sheath 810 in the first and second directions,respectively). In some embodiments and when the laser ablation catheter800 is in the watching mode, the fourth input 2016 may be actuated bythe clinician to cause the laser ablation catheter 800 to exit thewatching mode. The ninth visual indicator 2018 may indicate when thelaser ablation catheter 800 is in the watching mode.

In some embodiments, the control panel 2000 includes a tenth visualindicator 2020 (for example, a light-emitting diode) that indicates thepresence of a device error or fault condition (for example, as detectedby the catheter controller 848). For example, device errors and faultconditions may include the prime mover 840 rotating past a rotationallimit, a reduction in power to the prime mover 840, and the prime mover840 failing to rotate in response to actuation of one or more of theinputs 2002 and 2006.

In some embodiments, catheters according to the present disclosure mayinclude other types of prime movers for rotating the drive wire otherthan an electric motor. Such other types of prime movers may be, forexample, fluid-driven motors and/or pneumatic or hydraulic components.Replacing the electric or electronic components, including a battery todrive the electric or electronic components, with pneumatic or hydrauliccomponents reduces the potential difficulties associated withsterilizing a medical device containing such electric or electroniccomponents.

As an example and referring to FIG. 21, an embodiment of a laserablation catheter 2100 according to the present disclosure of isillustrated. The laser ablation catheter 2100 may be generally the sameor similar to any of the laser ablation catheters described herein (forexample, the laser ablation catheter 800), except that the laserablation catheter 2100 includes pneumatic components to rotate the drivewire 2130. The laser ablation catheter 2100 includes a first port 2102for detachably coupling to and receiving a pneumatic fluid (for example,a compressed gas, such as air or carbon dioxide) from a regulatedpneumatic fluid source 2104 (for example, a compressed air conduit in abuilding or a disposable cartridge). In some embodiments, the first port2102 is coupled to a stop valve 2106 that may be actuated to selectivelyinhibit flow of the pneumatic fluid through the pneumatic components.Specifically, as shown in the figures, the stop valve 2106 may be atwo-way, two-position valve. In some embodiments, the stop valve 2106may be operatively coupled to and actuated by a controller 2108, whichmay be any of the controllers described herein. The stop valve 2106 iscoupled to a directional control valve 2110, which is in turn coupled toa fluid-driven motor 2112 (that is, a motor that converts fluid motioninto mechanical rotation). The fluid-driven motor 2112 is coupled to androtatably drives a speed reducer 2114 (for example, a gearbox), which inturn rotatably drives the drive wire 2130.

Continuing to refer to FIG. 21, the directional control valve 2110selectively delivers the pneumatic fluid to the fluid-driven motor 2112via a first inlet/outlet port 2116 and permits the fluid-driven motor2112 to discharge the fluid via a second inlet/outlet port 2118 torotate the fluid-driven motor 2112 and the drive wire 2130 in a firstdirection. The directional control valve 2110 also selectively deliversthe pneumatic fluid to the fluid-driven motor 2112 via the secondinlet/outlet port 2118 and permits the fluid-driven motor 2112 todischarge the fluid via the first inlet/outlet port 2116 to rotate thefluid-driven motor 2112 and the drive wire 2130 in a second directionopposite the first direction.

In some embodiments, the directional control valve 2110 is a four-wayvalve that includes (1) a first port 2120 coupled to the stop valve2106; (2) a second port 2122 coupled to the first inlet/outlet port2116; (3) a third port 2124 coupled to the second inlet/outlet port2118; and (4) a fourth port 2126 for delivering the pneumatic fluid to areservoir 2128 (for example, discharging the fluid to atmosphere). Insome embodiments, such as those in which the stop valve 2106 is omitted,the directional control valve 2110 may be a four-way, three-positionvalve. In such embodiments, the directional control valve 2110 includes(1) a first position 2132 in which the valve 2110 delivers the fluid tothe first inlet/outlet port 2116 to rotate the fluid-driven motor 2112and the drive wire 2130 in the first direction; (2) a second position2134, or stop position, in which the valve 2110 inhibits flow of thefluid through the fluid-driven motor 2112; and (3) a third position 2136in which the valve 2110 delivers the fluid to the second inlet/outletport 2118 to rotate the fluid-driven motor 2112 and the drive wire 2130in the second direction.

In other embodiments, such as those in which the stop valve 2106 ispresent, the directional control valve 2110 may be a four-way,two-position valve, and the second position 2134 may be omitted. In someembodiments, the directional control valve 2110 may be operativelycoupled to and actuated by the controller 2108, and the controller 2108may actuate the valve 2110 such that the catheter 2100 is operable inany of the modes described herein (for example, the manual drive mode,the automatic mode, or the watching mode). In addition, the controller2108 may energize one or more of the visual indicators, such as any ofthe indicators described herein, based on a rotational position of thefluid-driven motor 2112 relative to the catheter housing.

Referring to FIG. 22, another example of an embodiment of a laserablation catheter 2200 according to the present disclosure of isillustrated. The laser ablation catheter 2200 may be generally the sameor similar to any of the laser ablation catheters described herein (forexample, the laser ablation catheter 800), except that the laserablation catheter 2200 includes hydraulic components to rotate the drivewire 2230. The laser ablation catheter 2200 includes a first port 2202for detachably coupling to and receiving a hydraulic fluid (for example,a pressurized liquid) from a hydraulic fluid source 2204 (for example, apump). In some embodiments, the first port 2202 is coupled to a stopvalve 2206 that may be actuated to selectively inhibit flow of thehydraulic fluid through the hydraulic components. Specifically, as shownin the figures, the stop valve 2206 may be a two-way, two-positionvalve. In some embodiments, the stop valve 2206 may be operativelycoupled to and actuated by a controller 2208, which may be any of thecontrollers described herein. The stop valve 2206 is coupled to adirectional control valve 2210, which is in turn coupled to afluid-driven motor 2212 (that is, a motor that converts fluid motioninto mechanical rotation). The fluid-driven motor 2212 is coupled to androtatably drives a speed reducer 2214 (for example, a gearbox), which inturn rotatably drives the drive wire 2230.

Continuing to refer to FIG. 22, the directional control valve 2210selectively delivers the hydraulic fluid to the fluid-driven motor 2212via a first inlet/outlet port 2216 and permits the fluid-driven motor2212 to discharge the fluid via a second inlet/outlet port 2218 torotate the fluid-driven motor 2212 and the drive wire 2230 in a firstdirection. The directional control valve 2210 also selectively deliversthe hydraulic fluid to the fluid-driven motor 2212 via the secondinlet/outlet port 2218 and permits the fluid-driven motor 2212 todischarge the fluid via the first inlet/outlet port 2216 to rotate thefluid-driven motor 2212 and the drive wire 2230 in a second directionopposite the first direction.

In some embodiments, the directional control valve 2210 is a four-wayvalve that includes (1) a first port 2220 coupled to the stop valve2206; (2) a second port 2222 coupled to the first inlet/outlet port2216; (3) a third port 2224 coupled to the second inlet/outlet port2218; and (4) a fourth port 2226 for delivering the hydraulic fluid to areservoir 2228. The fluid source 2204 may receive hydraulic fluid fromthe reservoir 2228. In some embodiments, such as those in which the stopvalve 2206 is omitted, the directional control valve 2210 may be afour-way, three-position valve. In such embodiments, the directionalcontrol valve 2210 includes (1) a first position 2232 in which the valve2210 delivers the fluid to the first inlet/outlet port 2216 to rotatethe fluid-driven motor 2212 and the drive wire 2230 in the firstdirection; (2) a second position 2234, or stop position, in which thevalve 2210 inhibits flow of the fluid through the fluid-driven motor2212; and (3) a third position 2236 in which the valve 2210 delivers thefluid to the second inlet/outlet port 2218 to rotate the fluid-drivenmotor 2212 and the drive wire 2230 in the second direction.

In other embodiments, such as those in which the stop valve 2206 ispresent, the directional control valve 2210 may be a four-way,two-position valve, and the second position 2234 may be omitted. In someembodiments, the directional control valve 2210 may be operativelycoupled to and actuated by the controller 2208, and the controller 2208may actuate the valve 2210 such that the catheter 2200 is operable inany of the modes described herein (for example, the manual drive mode,the automatic mode, or the watching mode). In addition, the controller2208 may energize one or more visual indicators, such as any of theindicators described herein, based on a rotational position of thefluid-driven motor 2212 relative to the catheter housing.

As yet another example and referring to FIG. 23, an embodiment of alaser ablation catheter 2300 according to the present disclosure of isillustrated. The laser ablation catheter 2300 may be generally the sameor similar to any of the laser ablation catheters described herein (forexample, the laser ablation catheter 800), except that the laserablation catheter 2300 includes hydraulic components to rotate the drivewire 2330. The laser ablation catheter 2300 includes a first port 2302for detachably coupling to and receiving a hydraulic fluid (for example,a liquid) from a hydraulic fluid source 2304 adapted to provide positiveand negative pressure (for example, a syringe). The first port 2302 iscoupled to a fluid-driven motor 2312 (that is, a motor that convertsfluid motion into mechanical rotation). The fluid-driven motor 2312 iscoupled to and rotatably drives a speed reducer 2314 (for example, agearbox), which in turn rotatably drives the drive wire 2330. Thehydraulic fluid source 2304 may be actuated in a first direction (forexample, the plunger of the syringe may be pushed in) to deliverhydraulic fluid from the source 2304 to the fluid-driven motor 2312 viaa first inlet/outlet port 2316 and discharge the fluid via a secondinlet/outlet port 2318 to rotate the fluid-driven motor 2312 and thedrive wire 2330 in a first direction. The discharged fluid is deliveredto a reservoir 2328. The hydraulic fluid source 2304 may be actuated ina second direction (for example, the plunger of the syringe may bepulled out) to draw hydraulic fluid from the reservoir 2328 and deliverthe fluid to the fluid-driven motor 2312 via the second inlet/outletport 2318, and the fluid is discharged from the fluid-driven motor 2312via the first inlet/outlet port 2316 to rotate the fluid-driven motor2312 and the drive wire 2330 in a second direction opposite the firstdirection. A controller 2308, which may be any of the controllersdescribed herein, may energize one or more visual indicators, such asany of the indicators described herein, based on a rotational positionof the fluid-driven motor 2312 relative to the catheter housing.

Laser ablation catheters according to the present disclosure may includeone or more orientation indictors that facilitate determining theorientation of the distal tip 2408, or outer band, within a subject whenviewed via medical imaging (for example, fluoroscopy). Referring now toFIGS. 24, 25A-25F, and 26A- 26J, an exemplary laser ablation cathetersheath 2410 is illustrated. The laser ablation catheter sheath 2410 maybe a part of a laser ablation catheter, such as the laser ablationcatheter 800 described above, and used instead of the sheath 810. Thatis, a laser ablation catheter including the laser ablation cathetersheath 2410 may have the same features as any of the laser ablationcatheters described herein (for example, the laser ablation catheter800), except that the sheath 2410 includes orientation indictors thatfacilitate determining the orientation of the distal tip 2408 within asubject. Alternatively, the laser ablation catheter sheath 2410 may be apart of other laser ablation catheters for which information regardingthe orientation of the distal tip 2408 within a subject may bebeneficial to the user. Such laser ablation catheters include, forexample, a distal tip 2408 having an eccentrically-positioned guide wirelumen and/or asymmetrically-positioned transport members (for example,optical fibers).

Generally and referring specifically to FIG. 24, the distal tip 2408, orouter band, of the laser ablation catheter sheath 2410 includes a wallor body 2409 that connects to a plurality of transport members 2404(which may be similar to the transport members 804 described above) thatare exposed through an eccentrically-disposed opening 2405, a drive wire2430 (which may be similar to the drive wire 830 described above), and aguide wire lumen 2435 (which may be similar to the guide wire lumen 835described above). At the distal tip 2408, the guide wire lumen 2435 iscoupled to the drive wire 2430 and the distal tip body 2409 by a firstconnection 2482 (for example, a welded connection). In addition, thefirst connection 2482, the drive wire 2430, and the transport members2404 are coupled to each other by a second connection 2484 (for example,an epoxy connection). The transport member opening 2405, the drive wire2430, and the guide wire lumen 2435 are eccentrically disposed relativeto the longitudinal axis 2411 of the distal tip 2408. Due to thisarrangement, the distal tip 2408 rotates in an “orbital” or “eccentric”manner about an eccentric axis when the drive wire 2430 rotates. Theeccentric rotation of the distal tip 2408 permits the transport members2404 to deliver laser energy and ablate tissue in a circular patternthat is larger than the distal tip 2408, or the distal tip 2408 may berotated such that the transport members 2404 move to a desired positionrelative to patient tissue prior to ablation.

Referring now to FIGS. 25A-25F, and 26A, 26C, 26E, and 26G, if thetransport members 2404 are to be moved to a desired position relative topatient tissue prior to ablation, the orientation indicators may be usedto determine the orientation of the distal tip 2408, and, as a result,the position of the transport members 2404 relative to patient tissue.The laser ablation catheter sheath 2410 illustrated in FIGS. 25A-25F,and 26A, 26C, 26E, and 26G includes orientation indicators that areformed as openings on the distal tip body 2409. The openings carry aradiolucent material, such as the material providing the secondconnection 2484 (for example, an epoxy) that couples the transportmembers 2404 to the body 2409. The body 2409 is formed of a radiopaquematerial and, as a result, the orientation indicators visually contrastwith the body 2409 (assuming that the body 2409 does not overlie orunderlie the orientation indicators, and the transport members 2404 areradiolucent) when viewed via medical imaging (for example, fluoroscopy).In some embodiments, the orientation indicators are formed as radiopaqueshapes on a radiolucent body 2409 (manufactured via, for example,physical vapor deposition using gold). In some embodiments, theorientation indicators are formed as shapes having a first radiopacityon a body 2409 having a second radiopacity, the first radiopacity beinggreater than the second radiopacity. In some embodiments, theorientation indicators are formed as shapes having a first radiopacityon a body 2409 having a second radiopacity, the first radiopacity beingless than the second radiopacity.

The positions of and the information provided by the orientationindicators (that is, the orientation of the distal tip 2408) will bedescribed with reference to a longitudinal axis 2411 of the body 2409 ofthe distal tip 2408, a circumferential direction 2450 along the outersurface 2452 of the distal tip 2408, and several planes defined by thebody 2409 of the distal tip 2408. Specifically and referringparticularly to FIG. 24, the body 2409 of the distal tip 2408 defines afirst axial plane 2454 along which the longitudinal axis 2411 extends,and the first axial plane 2454 bisects the guide wire lumen 2435. Thatis, the guide wire lumen 2435 is partially disposed on a first side 2456of the first axial plane 2454 and an opposite second side 2458 of thefirst axial plane 2454. The drive wire 2430 is disposed on the firstside 2456 of the first axial plane 2454. The body 2409 of the distal tip2408 also defines a second axial plane 2460 along which the longitudinalaxis 2411 extends, and the second axial plane 2460 is perpendicular tothe first axial plane 2454. The guide wire lumen 2435 is at leastpartially disposed on a first side 2462 of the second axial plane 2460,and the majority of the transport members 2404 (more specifically and asshown in the figures, all of the transport members 2404) are disposed onan opposite second side 2464 of the second axial plane 2460. The body2409 of the distal tip 2408 further defines a transverse plane 2466 thatis substantially perpendicular the longitudinal axis 2411 (that is,perpendicular±2.5 degrees). In some embodiments and as shown in thefigures, the distal tip body 2409 is asymmetric over the first axialplane 2454 and the second axial plane 2460.

The laser ablation catheter sheath 2410 illustrated in FIGS. 25A-25F,and 26A, 26C, 26E, and 26G includes a first orientation indicator 2518,a second orientation indicator 2520, and a third orientation indicator2522, although other embodiments of distal tips could include differentnumbers of orientation indicators. The first orientation indicator 2518,the second orientation indicator 2520, and the third orientationindicator 2522 are aligned with each other relative to the longitudinalaxis 2411 of the distal tip 2408, and the first orientation indicator2518, the second orientation indicator 2520, and the third orientationindicator 2522 are disposed apart from each other in the circumferentialdirection 2450 along the outer surface 2452 of the distal tip 2408. Morespecifically, the first orientation indicator 2518 is disposed on thefirst side 2456 of the first axial plane 2454 and the second side 2464of the second axial plane 2460, the second orientation indicator 2520 isdisposed on the second side 2458 of the first axial plane 2454 and thesecond side 2464 of the second axial plane 2460, and the thirdorientation indicator 2522 is disposed on the second side 2458 of thefirst axial plane 2454 and the first side 2462 of the second axial plane2460.

The first orientation indicator 2518 and the second orientationindicator 2520 are disposed such that when the distal tip 2408 is viewedin a first side view (see, for example, FIG. 26A), the first orientationindicator 2518 and the second orientation indicator 2520 overlap. Thatis, the body 2409 of the distal tip 2408 does not overlie or underliethe first orientation indicator 2518 and the second orientationindicator 2520 when the distal tip 2408 is viewed in the first sideview. As such, the first orientation indicator 2518 and the secondorientation indicator 2520 visually contrast with the body 2409 when thedistal tip 2408 is viewed in the first side view via medical imaging. Inaddition, the body 2409 of the distal tip 2408 overlies and obscures thethird orientation indicator 2522 when the distal tip 2408 is viewed inthe first side view.

In the first side view, the distal tip 2408, the drive wire 2430, and aguide wire 2624 together appear, for example, as shown in FIG. 26A undermedical imaging. Specifically, the guide wire 2624 and the drive wire2430 are disposed on the first side 2462 of the second axial plane 2460(and on one side of the longitudinal axis 2411—the left side as shown inFIG. 26A; the guide wire 2624 may underlie and thereby obscure the drivewire 2430) and the first orientation indicator 2518 is disposed on thesecond side 2464 of the second axial plane 2460 (and on the other sideof the longitudinal axis 2411—the right side as shown in FIG. 26A). Asdescribed above, the transport members 2404 are disposed on the secondside 2464 of the second axial plane 2460 and, as a result, the firstorientation indicator 2518 overlies the transport members 2404 in thefirst side view. Stated another way, these positions of the guide wire2624, the drive wire 2430, and the first orientation indicator 2518indicate that the transport members 2404 are disposed on the other sideof the longitudinal axis 2411 in the first side view.

The second orientation indicator 2520 and third orientation indicator2522 are disposed such that when the distal tip 2408 is viewed in asecond side view (see, for example, FIG. 26C), the third orientationindicator 2522 and the second orientation indicator 2520 overlap. Thatis, the body 2409 of the distal tip 2408 does not overlie or underliethe second orientation indicator 2520 and the third orientationindicator 2522 when the distal tip 2408 is viewed in the second sideview. As such, the second orientation indicator 2520 and the thirdorientation indicator 2522 visually contrast with the body 2409 when thedistal tip 2408 is viewed in the second side view via medical imaging.In addition, the body 2409 of the distal tip 2408 underlies and obscuresthe first orientation indicator 2518 when the distal tip 2408 is viewedin the second side view. The second side view is substantially 90degrees (that is, 90 degrees±2.5 degrees) apart from the first side viewabout the longitudinal axis 2411. That is, the distal tip 2408 movesfrom the first side view to the second side view when the distal tip2408 rotates substantially 90 degrees about the longitudinal axis 2411relative to the medical imaging equipment used for viewing the distaltip 2408.

In the second side view, the distal tip body 2409, the drive wire 2430,and the guide wire 2624 together appear, for example, as shown in FIG.26C under medical imaging. Specifically, the guide wire 2624 is bisectedby the first axial plane 2454 (and the longitudinal axis 2411), thedrive wire 2430 is disposed on the first side 2456 of the first axialplane 2454 (and on one side of the longitudinal axis 2411—the left sideas shown in FIG. 26C), and the second orientation indicator 2520 isdisposed on the second side 2458 of the first axial plane 2454 (and onthe other side of the longitudinal axis 2411—the right side as shown inFIG. 26C). These positions of the guide wire 2624, the drive wire 2430,and the second orientation indicator 2520 indicate that the transportmember opening 2405 is bisected by the longitudinal axis 2411 in thesecond side view. In addition, these positions of the guide wire 2624,the drive wire 2430, and the second orientation indicator 2520 indicatethat the transport members 2404 are disposed at a first, relativelyclose position to the medical imaging equipment in the second side view(compared to a view described below).

In a third side view (see, for example, FIG. 26E), the first orientationindicator 2518 and the second orientation indicator 2520 also overlap.That is, the body 2409 of the distal tip 2408 does not overlie orunderlie the first orientation indicator 2518 and the second orientationindicator 2520 when the distal tip 2408 is viewed in the third sideview. As such, the first orientation indicator 2518 and the secondorientation indicator 2520 visually contrast with the body 2409 when thedistal tip 2408 is viewed in the third side view via medical imaging. Inaddition, the body 2409 of the distal tip 2408 underlies and obscuresthe third orientation indicator 2522 when the distal tip 2408 is viewedin the third side view. The third side view is substantially 90 degrees(that is, 90 degrees±2.5 degrees) apart from the second side view aboutthe longitudinal axis 2411 and substantially 180 degrees (that is, 180degrees±2.5 degrees) apart from the first side view about thelongitudinal axis 2411. That is, the distal tip 2408 moves from thesecond side view to the third side view when the distal tip 2408 rotatessubstantially 90 degrees about the longitudinal axis 2411 relative tothe medical imaging equipment used for viewing the distal tip 2408.

In the third side view, the distal tip body 2409, the drive wire 2430,and the guide wire 2624 together appear, for example, as shown in FIG.26E under medical imaging. Generally, the distal tip body 2409, thedrive wire 2430, and the guide wire 2624 together appear to form themirror image of the components relative to the first side view (see, forexample, FIG. 26A). Specifically, the guide wire 2624 and the drive wire2430 are disposed on the first side 2462 of the second axial plane 2460(and on one side of the longitudinal axis 2411—the right side as shownin FIG. 26E; the guide wire 2624 may underlie and thereby obscure thedrive wire 2430) and the second orientation indicator 2520 is disposedon the second side 2464 of the second axial plane 2460 (and on the otherside of the longitudinal axis 2411—the left side as shown in FIG. 26E).The transport members 2404 are disposed on the second side 2464 of thesecond axial plane 2460 and, as a result, the second orientationindicator 2520 overlies the transport members 2404 in the third sideview. Stated another way, these positions of the guide wire 2624, thedrive wire 2430, and the first orientation indicator 2520 indicate thatthe transport members 2404 are disposed on the other side of thelongitudinal axis 2411 in the third side view.

In a fourth side view (see, for example, FIG. 26G), the thirdorientation indicator 2522 and the second orientation indicator 2520also overlap. That is, the body 2409 of the distal tip 2408 does notoverlie or underlie the second orientation indicator 2520 and the thirdorientation indicator 2522 when the distal tip 2408 is viewed in thefourth side view. As such, the second orientation indicator 2520 and thethird orientation indicator 2522 visually contrast with the body 2409when the distal tip 2408 is viewed in the fourth side view via medicalimaging. In addition, the body 2409 of the distal tip 2408 overlies andobscures the first orientation indicator 2518 when the distal tip 2408is viewed in the fourth side view. The fourth side view is substantially90 degrees (that is, 90 degrees±2.5 degrees) apart from the third sideview about the longitudinal axis 2411 and substantially 180 degrees(that is, 180 degrees±2.5 degrees) apart from the second side view aboutthe longitudinal axis 2411. That is, the distal tip 2408 moves from thethird side view to the fourth side view when the distal tip 2408 rotatessubstantially 90 degrees about the longitudinal axis 2411 relative tothe medical imaging equipment used for viewing the distal tip 2408.

In the fourth side view, the distal tip body 2409, the drive wire 2430,and the guide wire 2624 together appear, for example, as shown in FIG.26G under medical imaging. Generally, the distal tip body 2409, thedrive wire 2430, and the guide wire 2624 together appear to form themirror image of the components relative to the second side view (see,for example, FIG. 26C). Specifically, the guide wire 2624 is bisected bythe first axial plane 2454 (and the longitudinal axis 2411), the drivewire 2430 is disposed on the first side 2456 of the first axial plane2454 (and on one side of the longitudinal axis 2411—the right side asshown in FIG. 26G), and the third orientation indicator 2522 is disposedon the second side 2458 of the first axial plane 2454 (and on the otherside of the longitudinal axis 2411—the left side as shown in FIG. 26G).These positions of the guide wire 2624, the drive wire 2430, and thethird orientation indicator 2522 indicate that the transport memberopening 2405 is bisected by the longitudinal axis 2411 in the fourthside view. In addition, these positions of the guide wire 2624, thedrive wire 2430, and the third orientation indicator 2522 indicate thatthe transport members 2404 are disposed at a second, relatively farposition to the medical imaging equipment in the fourth side viewcompared to the second side view.

In some embodiments and as shown in the figures, one or more of thefirst orientation indicator 2518, the second orientation indicator 2520,and the third orientation indicator 2522 taper in the circumferentialdirection 2450 along the outer surface 2452 of the distal tip 2408.Stated another way, each of the first orientation indicator 2518, thesecond orientation indicator 2520, and the third orientation indicator2522 may taper from a first width to a second width (the widths being indirections parallel to the longitudinal axis 2411), and the second widthis less than the first width. For the first orientation indicator 2518in the first side view (see FIG. 26A), the first width 2626 is disposedbetween the second width 2628 and the longitudinal axis 2411. As such,the first orientation indicator 2518 appears to “point” away from thelongitudinal axis 2411 in the first side view. For the secondorientation indicator 2520 in the second side view (see FIG. 26C), thesecond width 2632 is disposed between the first width 2630 and thelongitudinal axis 2411. As such, the second orientation indicator 2520appears to point toward the longitudinal axis 2411 in the second sideview. For the second orientation indicator 2520 in the third side view(see FIG. 26E), the first width 2630 is disposed between the secondwidth 2632 and the longitudinal axis 2411. As such, the secondorientation indicator 2520 appears to point away from the longitudinalaxis 2411 in the third side view. For the third orientation indicator2522 in the fourth side view (see FIG. 26G), the second width 2636 isdisposed between the first width 2634 and the longitudinal axis 2411. Assuch, the third orientation indicator 2522 appears to point toward thelongitudinal axis 2411 in the fourth side view.

In some embodiments, one or more of the first orientation indicator2518, the second orientation indicator 2520, and the third orientationindicator 2522 have tapering shapes. For example, one or more of thefirst orientation indicator 2518, the second orientation indicator 2520,and the third orientation indicator 2522 may have triangular shapes, asshown in the figures, semi-circular shapes, semi-elliptical shapes,arrow shapes, or the like. In other embodiments, one or more of thefirst orientation indicator 2518, the second orientation indicator 2520,and the third orientation indicator 2522 have non-tapering shapes. Forexample, one or more of the first orientation indicator 2518, the secondorientation indicator 2520, and the third orientation indicator 2522 mayhave rectangular shapes or the like.

In some embodiments, one or two of the first orientation indicator 2518,the second orientation indicator 2520, and the third orientationindicator 2522 may have a different size than the remainingindicator(s). For example and as shown in the figures, the firstorientation indicator 2518 and the second orientation indicator 2520 mayhave the same size and the third orientation indicator 2522 may have asmaller size. Stated another way, the first orientation indicator 2518has a first surface area on the outer surface 2452 of the distal tip2408, the second orientation indicator 2520 has a second surface area onthe outer surface 2452 of the distal tip 2408, the second surface areais substantially equal to the first surface area (that is, equal±5percent), the third orientation indicator 2522 has a third surface areaon the outer surface 2452 of the distal tip 2408, and the third surfacearea is less than the first surface area. In other embodiments, all ofthe orientation indicators have the same size.

In some embodiments, one or more of the first orientation indicator2518, the second orientation indicator 2520, and the third orientationindicator 2522 have shapes that are symmetric over the transverse plane2466. For example, one or more of the first orientation indicator 2518,the second orientation indicator 2520, and the third orientationindicator 2522 may have triangular shapes, as shown in the figures,circular shapes, semi-circular shapes, elliptical shapes,semi-elliptical shapes, arrow shapes, or the like. In some cases,symmetric shapes may overlap and visually contrast with the distal tipbody 2409 in some intermediate side views between the side viewsdescribed above. In the intermediate side views, the orientationindicators overlap to appear as the same shape as in the side viewsdescribed above (for example, a triangular shape), except with a smallersize. More specifically, when the distal tip 2408 is viewed in the firstside view (see, for example, FIG. 26A), the first orientation indicator2518 and the second orientation indicator 2520 overlap and visuallycontrast with the body 2409 by appearing as a shape (for example, atriangular shape) having a first size (for example, a first area), andwhen the distal tip 2408 is viewed in a first intermediate side view(see, for example, FIG. 26I) between the first side view and the secondside view about the longitudinal axis 2411, the first orientationindicator 2518 and the second orientation indicator 2520 overlap andvisually contrast with the body 2409 by appearing as the shape (forexample, the triangular shape) having a second size (for example, asecond area), the second size being less than the first size. In someembodiments, there are a plurality of intermediate views between thefirst side view and the second side view.

In some embodiments, there may be one or more similar intermediate sizeviews between one or more of the second side view and the third sideview, the third side view and the fourth side view, and the fourth sideview and the first side view. For example, when the distal tip 2408 isviewed in the second side view (see, for example, FIG. 26C), the secondorientation indicator 2520 and the third orientation indicator 2522overlap and visually contrast with the body 2409 by appearing as a shape(for example, a triangular shape) having a first size (for example, afirst area), and when the distal tip 2408 is viewed in an intermediateside view (not shown) between the second side view and the third sideview about the longitudinal axis 2411, the second orientation indicator2520 and the third orientation indicator 2522 overlap and visuallycontrast with the body 2409 by appearing as the shape (for example, thetriangular shape) having a second size (for example, a second area), thesecond size being less than the first size. As another example, when thedistal tip 2408 is viewed in the third side view (see, for example, FIG.26E), the second orientation indicator 2520 and the first orientationindicator 2518 overlap and visually contrast with the body 2409 byappearing as a shape (for example, a triangular shape) having a firstsize (for example, a first area), and when the distal tip 2408 is viewedin an intermediate side view (not) between the third side view and thefourth side view about the longitudinal axis 2411, the secondorientation indicator 2520 and the first orientation indicator 2518overlap and visually contrast with the body 2409 by appearing as theshape (for example, the triangular shape) having a second size (forexample, a second area), the second size being less than the first size.As yet another example, when the distal tip 2408 is viewed in the fourthside view (see, for example, FIG. 26G), the third orientation indicator2522 and the second orientation indicator 2520 overlap and visuallycontrast with the body 2409 by appearing as a shape (for example, atriangular shape) having a first size (for example, a first area), andwhen the distal tip 2408 is viewed in an intermediate side view (notshown) between the fourth side view and the first side view about thelongitudinal axis 2411, the third orientation indicator 2522 and thesecond orientation indicator 2520 overlap and visually contrast with thebody 2409 by appearing as the shape (for example, the triangular shape)having a second size (for example, a second area), the second size beingless than the first size.

In some embodiments, such as those described below, one or more of theorientation indicators are asymmetric over the transverse plane.Referring now to FIGS. 27, 28A-28F, and 29A-29P, another exemplary laserablation catheter sheath 2710 is illustrated. The laser ablationcatheter sheath 2710 may be a part of a laser ablation catheter, such asthe laser ablation catheter 800 described above, and used instead of thesheath 810. That is, a laser ablation catheter including the laserablation catheter sheath 2710 may have the same features as any of thelaser ablation catheters described herein (for example, the laserablation catheter 800), except that the sheath 2710 includes orientationindictors that facilitate determining the orientation of the distal tip2708 within a subject. Alternatively, the laser ablation catheter sheath2710 may be a part of other laser ablation catheters for whichinformation regarding the orientation of the distal tip 2708 within asubject may be beneficial to the user. Such laser ablation cathetersinclude, for example, a distal tip 2708 having aneccentrically-positioned guide wire lumen and/orasymmetrically-positioned transport members (for example, opticalfibers).

Generally and referring specifically to FIG. 27, the distal tip 2708, orouter band, of the laser ablation catheter sheath 2710 includes a wallor body 2709 that connects to a plurality of transport members 2704(which may be similar to the transport members 804 described above) thatare exposed through an eccentrically-disposed opening 2705, a drive wire2730 (which may be similar to the drive wire 830 described above), and aguide wire lumen 2735 (which may be similar to the guide wire lumen 835described above). At the distal tip 2708, the guide wire lumen 2735 iscoupled to the drive wire 2730 and the distal tip body 2709 by a firstconnection 2782 (for example, a welded connection). In addition, thefirst connection 2782, the drive wire 2730, and the transport members2704 are coupled to each other by a second connection 2784 (for example,an epoxy connection). The transport member opening 2705, the drive wire2730, and the guide wire lumen 2735 are eccentrically disposed relativeto the longitudinal axis 2711 of the distal tip 2708. Due to thisarrangement, the distal tip 2708 rotates in an “orbital” or “eccentric”manner about an eccentric axis when the drive wire 2730 rotates. Theeccentric rotation of the distal tip 2708 permits the transport members2704 to deliver laser energy and ablate tissue in a circular patternthat is larger than the distal tip 2708, or the distal tip 2708 may berotated such that the transport members 2704 move to a desired positionrelative to patient tissue prior to ablation.

Referring now to FIGS. 28A-28F, 29A, 29C, 29E, and 29G, if the transportmembers 2704 are to be moved to a desired position relative to patienttissue prior to ablation, the orientation indicators may be used todetermine the orientation of the distal tip 2708, and, as a result, theposition of the transport members 2704 relative to patient tissue. Thelaser ablation catheter sheath 2710 illustrated in FIGS. 28A-28F, 29A,29C, 29E, and 29G includes orientation indicators that are formed asopenings and channels on the distal tip body 2709. The openings andchannels carry a radiolucent material, such as the material providingthe second connection 2784 (for example, an epoxy) that couples thetransport members 2704 to the body 2709. The body 2709 is formed of aradiopaque material and, as a result, the orientation indicatorsvisually contrast with the body 2709 (assuming that the body 2709 doesnot overlie or underlie the orientation indicators, and the transportmembers 2704 are radiolucent) when viewed via medical imaging (forexample, fluoroscopy). In some embodiments, the orientation indicatorsare formed as radiopaque shapes on a radiolucent body 2709 (manufacturedvia, for example, physical vapor deposition using gold). In someembodiments, the orientation indicators are formed as shapes having afirst radiopacity on a body 2709 having a second radiopacity, the firstradiopacity being greater than the second radiopacity. In someembodiments, the orientation indicators are formed as shapes having afirst radiopacity on a body 2709 having a second radiopacity, the firstradiopacity being less than the second radiopacity.

The positions of and the information provided by the orientationindicators (that is, the orientation of the distal tip 2708) will bedescribed with reference to a longitudinal axis 2711 of the body 2709 ofthe distal tip 2708, a circumferential direction 2750 along the outersurface 2752 of the distal tip 2708, and several planes defined by thebody 2709 of the distal tip 2708. Specifically and referringparticularly to FIG. 27, the body 2709 of the distal tip 2708 defines afirst axial plane 2754 along which the longitudinal axis 2711 extends,and the first axial plane 2754 bisects the guide wire lumen 2735. Thatis, the guide wire lumen 2735 is partially disposed on a first side 2756of the first axial plane 2754 and an opposite second side 2758 of thefirst axial plane 2754. The drive wire 2730 is disposed on the firstside 2756 of the first axial plane 2754. The body 2709 of the distal tip2708 also defines a second axial plane 2760 along which the longitudinalaxis 2711 extends, and the second axial plane 2760 is perpendicular tothe first axial plane 2754. The guide wire lumen 2735 is at leastpartially disposed on a first side 2762 of the second axial plane 2760,and the majority of the transport members 2704 (more specifically and asshown in the figures, all of the transport members 2704) are disposed onan opposite second side 2764 of the second axial plane 2760. The body2709 of the distal tip 2708 further defines a transverse plane 2766 thatis substantially perpendicular the longitudinal axis 2711 (that is,perpendicular±2.5 degrees). In some embodiments and as shown in thefigures, the distal tip body 2709 is asymmetric over the first axialplane 2754 and the second axial plane 2760.

The laser ablation catheter sheath 2710 illustrated in FIGS. 28A-28F,29A, 29C, 29E, and 29G includes a first orientation indicator 2818 and asecond orientation indicator 2820, although other embodiments of distaltips could include different numbers of orientation indicators. Thefirst orientation indicator 2818 and the second orientation indicator2820 are aligned with each other relative to the longitudinal axis 2711of the distal tip 2708, and the first orientation indicator 2818 and thesecond orientation indicator 2820 are disposed apart from each other inthe circumferential direction 2750 along the outer surface 2752 of thedistal tip 2708. More specifically, the first orientation indicator 2818is disposed on the first side 2756 of the first axial plane 2754 and thesecond side 2764 of the second axial plane 2760, the second orientationindicator 2820 is disposed on the second side 2758 of the first axialplane 2754 and intersected by (more particularly, bisected by) thesecond axial plane 2760.

As described briefly above, the first orientation indicator 2818 and thesecond orientation indicator 2820 are formed as openings and channels onthe distal tip body 2709. More specifically, the first orientationindicator 2818 is formed as an opening in communication with thetransport member opening 2705. The second orientation indicator 2820 isformed together by a first portion 2824 and a second portion 2826. Thefirst portion 2824 of the second orientation indicator 2820 is formed asan opening in communication with the transport member opening 2705, andfirst portion 2824 of the second orientation indicator 2820 is disposedon the second side 2764 of the second axial plane 2760. The firstportion 2824 is coupled to the second portion 2826 of the secondorientation indicator 2820, which is formed together by an outer channel2828 and an inner channel 2830 on the outer surface 2752 of the distaltip body 2709. The second portion 2826 of the second orientationindicator 2820 is disposed on the first side 2762 of the second axialplane 2760.

The first orientation indicator 2818 and the second orientationindicator 2820 are disposed such that when the distal tip 2708 is viewedin a first side view (see, for example, FIG. 29A), the first orientationindicator 2818 and the first portion 2824 of the second orientationindicator 2820 overlap. That is, the body 2709 of the distal tip 2708does not overlie or underlie the first orientation indicator 2818 andthe first portion 2824 of the second orientation indicator 2820 when thedistal tip 2708 is viewed in the first side view. As such, the firstorientation indicator 2818 and the first portion 2824 of the secondorientation indicator 2820 visually contrast with the body 2709 when thedistal tip 2708 is viewed in the first side view via medical imaging. Inaddition, the body 2709 of the distal tip 2708 overlies and obscures thesecond portion 2826 of the second orientation indicator 2820 when thedistal tip 2708 is viewed in the first side view.

In the first side view, the distal tip 2708, the drive wire 2730, and aguide wire 2924 together appear, for example, as shown in FIG. 29A undermedical imaging. Specifically, the guide wire 2924 and the drive wire2730 are disposed on the first side 2762 of the second axial plane 2760(and on one side of the longitudinal axis 2711—the left side as shown inFIG. 29A; the guide wire 2924 may underlie and thereby obscure the drivewire 2730) and the first orientation indicator 2818 is disposed on thesecond side 2764 of the second axial plane 2760 (and on the other sideof the longitudinal axis 2711—the right side as shown in FIG. 29A). Asdescribed above, the transport members 2704 are disposed on the secondside 2764 of the second axial plane 2760 and, as a result, the firstorientation indicator 2818 overlies the transport members 2704 in thefirst side view. Stated another way, these positions of the guide wire2924, the drive wire 2730, and the first orientation indicator 2818indicate that the transport members 2704 are disposed on the other sideof the longitudinal axis 2711 in the first side view.

The first portion 2824 and the second portion 2826 of the secondorientation indicator 2820 are disposed such that when the distal tip2708 is viewed in a second side view (see, for example, FIG. 29C), thefirst portion 2824 and the second portion 2826 of the second orientationindicator 2820 overlap. That is, the body 2709 of the distal tip 2708does not overlie or underlie the first portion 2824 or the secondportion 2826 of the second orientation indicator 2820 when the distaltip 2708 is viewed in the second side view. As such, the secondorientation indicator 2820 visually contrasts with the body 2709 whenthe distal tip 2708 is viewed in the second side view via medicalimaging. In addition, the body 2709 of the distal tip 2708 underlies andobscures the first orientation indicator 2818 when the distal tip 2708is viewed in the second side view. The second side view is substantially90 degrees (that is, 90 degrees±2.5 degrees) apart from the first sideview about the longitudinal axis 2711. That is, the distal tip 2708moves from the first side view to the second side view when the distaltip 2708 rotates substantially 90 degrees about the longitudinal axis2711 relative to the medical imaging equipment used for viewing thedistal tip 2708.

In the second side view, the distal tip body 2709, the drive wire 2730,and the guide wire 2924 together appear, for example, as shown in FIG.29C under medical imaging. Specifically, the guide wire 2924 is bisectedby the first axial plane 2754 (and the longitudinal axis 2711), thedrive wire 2730 is disposed on the first side 2756 of the first axialplane 2754 (and on one side of the longitudinal axis 2711—the left sideas shown in FIG. 29C), and the second orientation indicator 2820 isdisposed on the second side 2758 of the first axial plane 2754 (and onthe other side of the longitudinal axis 2711—the right side as shown inFIG. 29C). These positions of the guide wire 2924, the drive wire 2730,and the second orientation indicator 2820 indicate that the transportmember opening 2705 is bisected by the longitudinal axis 2711 in thesecond side view. In addition, these positions of the guide wire 2924,the drive wire 2730, and the second orientation indicator 2820 indicatethat the transport members 2704 are disposed at a first, relativelyclose position to the medical imaging equipment in the second side view(compared to a view described below).

In a third side view (see, for example, FIG. 29E), the first orientationindicator 2818 and the first portion 2824 of the second orientationindicator 2820 also overlap. That is, the body 2709 of the distal tip2708 does not overlie or underlie the first orientation indicator 2818and the first portion 2824 of the second orientation indicator 2820 whenthe distal tip 2708 is viewed in the third side view. As such, the firstorientation indicator 2818 and the first portion 2824 of the secondorientation indicator 2820 visually contrast with the body 2709 when thedistal tip 2708 is viewed in the third side view via medical imaging. Inaddition, the body 2709 of the distal tip 2708 underlies and obscuresthe second portion 2826 of the second orientation indicator 2820 whenthe distal tip 2708 is viewed in the third side view. The third sideview is substantially 90 degrees (that is, 90 degrees±2.5 degrees) apartfrom the second side view about the longitudinal axis 2711 andsubstantially 180 degrees (that is, 180 degrees±2.5 degrees) apart fromthe first side view about the longitudinal axis 2711. That is, thedistal tip 2708 moves from the second side view to the third side viewwhen the distal tip 2708 rotates substantially 90 degrees about thelongitudinal axis 2711 relative to the medical imaging equipment usedfor viewing the distal tip 2708.

In the third side view, the distal tip body 2709, the drive wire 2730,and the guide wire 2924 together appear, for example, as shown in FIG.29E under medical imaging. Generally, the distal tip body 2709, thedrive wire 2730, and the guide wire 2924 together appear to form themirror image of the components relative to the first side view (see, forexample, FIG. 29A). Specifically, the guide wire 2924 and the drive wire2730 are disposed on the first side 2762 of the second axial plane 2760(and on one side of the longitudinal axis 2711—the right side as shownin FIG. 29E; the guide wire 2924 may underlie and thereby obscure thedrive wire 2730) and the first portion 2824 of the second orientationindicator 2820 is disposed on the second side 2764 of the second axialplane 2760 (and on the other side of the longitudinal axis 2711—the leftside as shown in FIG. 29E). The transport members 2704 are disposed onthe second side 2764 of the second axial plane 2760 and, as a result,the first portion 2824 of the second orientation indicator 2820 overliesthe transport members 2704 in the third side view. Stated another way,these positions of the guide wire 2924, the drive wire 2730, and thesecond orientation indicator 2820 indicate that the transport members2704 are disposed on the other side of the longitudinal axis 2711 in thethird side view.

In a fourth side view (see, for example, FIG. 29G), the first portion2824 and the second portion 2826 of the second orientation indicator2820 also overlap. That is, the body 2709 of the distal tip 2708 doesnot overlie or underlie the first portion 2824 or the second portion2826 of the second orientation indicator 2820 when the distal tip 2708is viewed in the fourth side view. As such, the second orientationindicator 2820 visually contrasts with the body 2709 when the distal tip2708 is viewed in the fourth side view via medical imaging. In addition,the body 2709 of the distal tip 2708 overlies and obscures the firstorientation indicator 2818 when the distal tip 2708 is viewed in thefourth side view. The fourth side view is substantially 90 degrees (thatis, 90 degrees±2.5 degrees) apart from the third side view about thelongitudinal axis 2711 and substantially 180 degrees (that is, 180degrees±2.5 degrees) apart from the second side view about thelongitudinal axis 2711. That is, the distal tip 2708 moves from thethird side view to the fourth side view when the distal tip 2708 rotatessubstantially 90 degrees about the longitudinal axis 2711 relative tothe medical imaging equipment used for viewing the distal tip 2708.

In the fourth side view, the distal tip body 2709, the drive wire 2730,and the guide wire 2924 together appear, for example, as shown in FIG.29G under medical imaging. Generally, the distal tip body 2709, thedrive wire 2730, and the guide wire 2924 together appear to form themirror image of the components relative to the second side view (see,for example, FIG. 29C). Specifically, the guide wire 2924 is bisected bythe first axial plane 2754 (and the longitudinal axis 2711), the drivewire 2730 is disposed on the first side 2756 of the first axial plane2754 (and on one side of the longitudinal axis 2711—the right side asshown in FIG. 29G), and the second orientation indicator 2820 isdisposed on the second side 2758 of the first axial plane 2754 (and onthe other side of the longitudinal axis 2711—the left side as shown inFIG. 29G). These positions of the guide wire 2924, the drive wire 2730,and the second orientation indicator 2820 indicate that the transportmember opening 2705 is bisected by the longitudinal axis 2711 in thefourth side view. In addition, these positions of the guide wire 2924,the drive wire 2730, and the second orientation indicator 2820 indicatethat the transport members 2704 are disposed at a second, relatively farposition to the medical imaging equipment in the fourth side viewcompared to the second side view.

In some embodiments, one or both of the first orientation indicator 2818and the second orientation indicator 2820 have asymmetric shapes (forexample, shapes that are asymmetric over the transverse plane 2766)and/or alphanumeric shapes (that is, the shapes of numbers, such as anynumber from zero to nine, or the shapes of letters, such as any letterfrom A to Z, and, as a specific example, the L-shape shown in thefigures). As a result, in the first side view (see, for example, FIG.29A) the first orientation indicator 2818 and the second orientationindicator 2820 overlap, appear as an asymmetric and/or alphanumericshape, and visually contrast with the distal tip body 2709. In thesecond side view (see, for example, FIG. 29C), the second orientationindicator appears as the asymmetric and/or alphanumeric shape andvisually contrasts with the distal tip body 2709. In some embodiments,the asymmetric and/or alphanumeric shape appears to be different sizesin the different side views. Stated another way and as an example, theasymmetric and/or alphanumeric shape has a first area when the distaltip 2708 is viewed in the first side view, the asymmetric and/oralphanumeric shape has a second area when the distal tip 2708 is viewedin the second side view, and the second area is different than the firstarea. More specifically, the second area may be less than the firstarea.

In some cases the first orientation indicator 2818 and the secondorientation indicator 2820 may overlap and visually contrast with thedistal tip body 2709, or one or both of the orientation indicators 2818and 2820 may themselves visually contrast with the distal tip body 2709,in some intermediate side views between the side views described above.In the intermediate side views, the orientation indicators 2818 and 2820overlap to appear, or one or both of the orientation indicators 2818 and2820 may themselves appear, as a different shape than in the side viewsdescribed above (for example, a symmetric shape and/or anon-alphanumeric shape). As a specific example, when the distal tip 2708is viewed in a first intermediate side view (see, for example, FIG. 29I)between the first side view and the second side view about thelongitudinal axis 2711, the first orientation indicator 2818 and thesecond orientation indicator 2820 overlap and visually contrast with thebody 2709 by appearing as a different shape 2940 (for example, asymmetric shape and/or a non-alphanumeric shape, such as a rectangle).In some embodiments, there are a plurality of intermediate views betweenthe first side view and the second side view.

In some embodiments, there may be one or more similar intermediate sizeviews between one or more of the second side view and the third sideview, the third side view and the fourth side view, and the fourth sideview and the first side view. For example, when the distal tip 2708 isviewed in a second intermediate side view (see, for example, FIG. 29K)between the second side view and the third side view about thelongitudinal axis 2711, the first orientation indicator 2818 and thesecond orientation indicator 2820 overlap and visually contrast with thebody 2709 by appearing as a different shape 2942 (for example, asymmetric shape and/or a non-alphanumeric shape, such as a rectangle).As another example, when the distal tip 2708 is viewed in a thirdintermediate side view (see, for example, FIG. 29M) between the thirdside view and the fourth side view about the longitudinal axis 2711, thefirst orientation indicator 2818 and the second orientation indicator2820 overlap and visually contrast with the body 2709 by appearing as afirst different shape 2944 (for example, a symmetric shape and/or anon-alphanumeric shape, such as a rectangle), and the second orientationindicator 2820 itself appears as a second different shape 2946 (forexample, a symmetric shape and/or a non-alphanumeric shape, such as arectangle). As yet another example, when the distal tip 2708 is viewedin a fourth intermediate side view (see, for example, FIG. 29O) betweenthe fourth side view and the first side view about the longitudinal axis2711, the first orientation indicator 2818 itself appears as a firstdifferent shape 2948 (for example, a symmetric shape and/or anon-alphanumeric shape, such as a rectangle), and the second orientationindicator 2820 itself appears as a second different shape 2950 (forexample, a symmetric shape and/or a non-alphanumeric shape, such as arectangle).

In some embodiments and as shown in the figures, one or both of thefirst orientation indicator 2818 and the second orientation indicator2820 are disposed such that the indicator 2818 and/or 2820 “points” in acertain direction in one or more of the side views described above.Stated another way, in some embodiments the first orientation indicator2818 and the second orientation indicator 2820 have a shape (forexample, an asymmetric shape or an alphanumeric shape) both a firstwidth and a second width (the widths being in directions parallel to thelongitudinal axis 2711), and the second width is less than the firstwidth. For the first orientation indicator 2818 in the first side view(see FIG. 29A), the first width 2926 is disposed between the secondwidth 2928 and the longitudinal axis 2711. As such, the firstorientation indicator 2818 appears to “point” away from the longitudinalaxis 2711 in the first side view. For the second orientation indicator2820 in the second side view (see FIG. 29C), the second width 2932 isdisposed between the first width 2930 and the longitudinal axis 2711. Assuch, the second orientation indicator 2820 appears to point toward thelongitudinal axis 2711 in the second side view. For the secondorientation indicator 2820 in the third side view (see FIG. 29E), thefirst width 2930 is disposed between the second width 2932 and thelongitudinal axis 2711. As such, the second orientation indicator 2820appears to point away from the longitudinal axis 2711 in the third sideview. For the second orientation indicator 2820 in the fourth side view(see FIG. 29G), the second width 2932 is disposed between the firstwidth 2930 and the longitudinal axis 2711. As such, the secondorientation indicator 2820 appears to point toward the longitudinal axis2711 in the fourth side view.

In some embodiments, the systems and methods of this disclosure may beimplemented in conjunction with a special purpose computer, a programmedmicroprocessor or microcontroller and peripheral integrated circuitelement(s), an ASIC or other integrated circuit, a digital signalprocessor, a hard-wired electronic or logic circuit such as discreteelement circuit, a programmable logic device or gate array such as PLD,PLA, FPGA, PAL, special purpose computer, any comparable means, or thelike. In general, any device(s) or means capable of implementing themethodology illustrated herein may be used to implement the variousaspects of this disclosure. Exemplary hardware that may be used for thedisclosed embodiments, configurations and aspects includes computers,handheld devices, telephones (e.g., cellular, Internet enabled, digital,analog, hybrids, and others), and other hardware known in the art. Someof these devices include processors (e.g., a single or multiplemicroprocessors), memory, nonvolatile storage, input devices, and outputdevices. Furthermore, alternative software implementations including,but not limited to, distributed processing or component/objectdistributed processing, parallel processing, or virtual machineprocessing may also be constructed to implement the methods describedherein.

The foregoing discussion has been presented for purposes of illustrationand description. The foregoing is not intended to limit the disclosureto the form or forms disclosed herein. In the foregoing Summary forexample, various features of the disclosure are grouped together in oneor more aspects, embodiments, and/or configurations for the purpose ofstreamlining the disclosure. The features of the aspects, embodiments,and/or configurations of the disclosure may be combined in alternateaspects, embodiments, and/or configurations other than those discussedabove. This method of disclosure is not to be interpreted as reflectingan intention that the claims require more features than are expresslyrecited in each claim. Rather, as the following claims reflect,inventive aspects lie in less than all features of a single foregoingdisclosed aspect, embodiment, and/or configuration. Thus, the followingclaims are hereby incorporated into this Summary, with each claimstanding on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the description has included description of one or moreaspects, embodiments, and/or configurations and certain variations andmodifications, other variations, combinations, and modifications arewithin the scope of the disclosure, e.g., as may be within the skill andknowledge of those in the art, after understanding the presentdisclosure. It is intended to obtain rights which include alternativeaspects, embodiments, and/or configurations to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A laser ablation catheter for providing treatmentto a subject, the laser ablation catheter comprising: a distal tipcomprising: a body defining a longitudinal axis; a first orientationindicator formed on the body, the first orientation indicator having analphanumeric shape; a second orientation indicator formed on the body,the second orientation indicator disposed relative to the firstorientation indicator such that when the distal tip is viewed in a firstside view, the second orientation indicator and the first orientationindicator overlap, appear as the alphanumeric shape, and visuallycontrast with the body, and the second orientation indicator configuredsuch that when the distal tip is viewed in a second side view, thesecond orientation indicator appears as the alphanumeric shape andvisually contrasts with the body, the second side view and the firstside view being substantially 90 degrees apart about the longitudinalaxis; a plurality of transport members carried by the distal tip anddisposed in an eccentric arrangement relative to the longitudinal axis,the plurality of transport members adapted to transmit laser energy. 2.The laser ablation catheter of claim 1, wherein the distal tip furthercomprises a guide wire lumen eccentrically disposed relative to thelongitudinal axis.
 3. The laser ablation catheter of claim 1, whereinthe body further defines: a first axial plane along which thelongitudinal axis extends, the first axial plane bisecting the guidewire lumen; and a second axial plane along which the longitudinal axisextends; the second axial plane being perpendicular to the first axialplane; wherein the guide wire lumen is at least partially disposed on afirst side of the second axial plane, and a majority of the transportmembers are disposed on a second side of the second axial plane, thesecond side being opposite the first side.
 4. The laser ablationcatheter of claim 1, wherein the first orientation indicator is disposedon the second side of the second axial plane and the second orientationindicator is bisected by the second axial plane.
 5. The laser ablationcatheter of claim 1, wherein the body obscures the first orientationindicator when the distal tip is viewed in the second side view viamedical imaging.
 6. The laser ablation catheter of claim 1, wherein thefirst orientation indicator and the second orientation indicator areasymmetric over a transverse plane, the transverse plane beingsubstantially perpendicular to the longitudinal axis.
 7. The laserablation catheter of claim 6, wherein the alphanumeric shape is anL-shape.
 8. The laser ablation catheter of claim 1, wherein the firstorientation indicator is formed as an opening on the body, and thesecond orientation indicator is formed as a channel formed on the body.9. The laser ablation catheter of claim 8, wherein the body furthercomprises a transport member opening in which the plurality of transportmembers are carried, the first orientation indicator and the secondorientation indicator in communication with the transport memberopening.
 10. The laser ablation catheter of claim 9, wherein the distaltip further comprises a radiolucent material carried in the transportmember opening, the first orientation indicator, and the secondorientation indicator.
 11. The laser ablation catheter of claim 1,wherein the alphanumeric shape has a first area when the distal tip isviewed in the first side view, the alphanumeric shape has a second areawhen the distal tip is viewed in the second side view, and the secondarea is different than the first area.
 12. The laser ablation catheterof claim 11, wherein the second area is less than the first area. 13.The laser ablation catheter of claim 1, wherein, when the distal tip isviewed in a first intermediate side view between the first side view andthe second side view about the longitudinal axis, the second orientationindicator and the first orientation indicator overlap and visuallycontrast with the body by appearing as a second shape, the second shapebeing different the alphanumeric shape.
 14. The laser ablation catheterof claim 13, wherein the second shape is a non-alphanumeric shape. 15.The laser ablation catheter of claim 13, wherein alphanumeric shape isan asymmetric shape and the second shape is a symmetric shape.
 16. Thelaser ablation catheter of claim 15, wherein alphanumeric shape is anL-shape and the second shape is a rectangle.
 17. A laser ablationcatheter for providing treatment to a subject, the laser ablationcatheter comprising: a distal tip comprising: a body comprising: alongitudinal axis; a guide wire lumen eccentrically disposed relative tothe longitudinal axis; a first axial plane along which the longitudinalaxis extends, the first axial plane bisecting the guide wire lumen, andthe body being asymmetric over the first axial plane; a firstorientation indicator formed on the body, the first orientationindicator having an asymmetric shape; a second orientation indicatorformed on the body, the second orientation indicator disposed relativeto the first orientation indicator such that when the distal tip isviewed in a first side view, the second orientation indicator and thefirst orientation indicator overlap, appear as the asymmetric shape, andvisually contrast with the body, and the second orientation indicatorconfigured such that when the distal tip is viewed in a second sideview, the second orientation indicator appears as the asymmetric shapeand visually contrasts with the body, the second side view and the firstside view being substantially 90 degrees apart about the longitudinalaxis; a plurality of transport members carried by the distal tip anddisposed in an eccentric arrangement relative to the longitudinal axis,the plurality of transport members adapted to transmit laser energy. 18.The laser ablation catheter of claim 17, wherein, when the distal tip isviewed in a first intermediate side view between the first side view andthe second side view about the longitudinal axis, the second orientationindicator and the first orientation indicator overlap and visuallycontrast with the body by appearing as a second shape, the second shapebeing different the asymmetric shape.
 19. The laser ablation catheter ofclaim 18, wherein the second shape is a symmetric shape.
 20. The laserablation catheter of claim 17, wherein the asymmetric shape has a firstarea when the distal tip is viewed in the first side view, theasymmetric shape has a second area when the distal tip is viewed in thesecond side view, and the second area is different than the first area.